u.s. product catalog...march 2019 u.s. product catalog new products: sevelamer hydrochloride...

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MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE VALERATE OINTMENT USP, 0.2% CALCIPOTRIENE OINTMENT USP, 0.005% ATOVAQUONE ORAL SUSPENSION USP, 750 MG/5 ML

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Page 1: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

MARCH 2019

U.S. PRODUCT CATALOG

NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG

FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS)

HYDROCORTISONE VALERATE OINTMENT USP, 0.2%

CALCIPOTRIENE OINTMENT USP, 0.005%

ATOVAQUONE ORAL SUSPENSION USP, 750 MG/5 ML

Page 2: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

1

B U S I N E S S T E R M S

Glenmark Pharmaceuticals Inc., USA is pleased to provide our customers with this comprehensive Product Catalog. Please note that the products within this catalog are only available for sale in the United States.

Although every effort has been made to ensure the accuracy of product descriptions and photos, it is important to note that the product images are not actual size and color may vary slightly. The information presented is to be used only as a reference guide.

Full Prescribing Information

Full prescribing information, including Black Box Warning, Medication Guides, and/or Patient Labeling [where applicable] can be found within our online Product Catalog, contained in the Products section of our website: www.glenmarkpharma.com/usa.

Therapeutic Equivalence [TE] Codes

The FDA evaluates approved products as therapeutically equivalent to other pharmaceutically equivalent products and assigns each with a TE Code. These codes are published in the FDA’s Orange Book. A brief explanation of the ‘A’ codes can be found below:

AA Products in conventional dosage forms not presenting bioequivalence problems

AB Products meeting necessary bioequivalence requirements

AB1 Products meeting necessary bioequivalence requirements, assigned when more than one reference listed drug of the same strength has been designated under the same heading

AB2 Products meeting necessary bioequivalence requirements, assigned when more than one reference listed drug of the same strength has been designated under the same heading

AB3 Products meeting necessary bioequivalence requirements, assigned when more than one reference listed drug of the same strength has been designated under the same heading

AN Solutions and powders for aerosolization

AO Injectable oil solutions

AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions

AT Topical Products

Ordering Information

Glenmark values the relationships with our customers who are authorized to distribute our products. To place an order, or learn how to become an Authorized Distributor of Record, please use the contact information below:

Glenmark Pharmaceuticals Inc., USA 750 Corporate Drive Mahwah, NJ 07430

Customer Service Hours 8:00am – 5:00pm EST Phone: 201-684-8000 Fax: 201-831-0080 Purchase order fax: 201-831-0086 Purchase order email: [email protected]

Remit to: P.O. Box 10354 Uniondale, NY 11555

Minimum Order Requirements The minimum order for each SKU is one case pack. The total order must exceed $250.00

All orders will be shipped using Glenmark’s preferred method of transportation. If expedited shipping or special handling is requested, Glenmark reserves the right to charge the customer for these additional expenses accordingly.

Brand Names & Trademarks

All brand names and trademarks used in this catalog are the property of their respective owners.

Page 3: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Acamprosate Calcium Delayed-Release Tablets 68462-0435-18 Rx 333 mg 180 Campral® AB

Acyclovir Ointment USP, 5%

68462-0746-17 Rx 5% 15 g Zovirax® AB

68462-0746-35 Rx 5% 30 g Zovirax® AB

Adapalene Gel, 0.1% 68462-0403-55 Rx 0.1% 45 g Differin® AB

Alclometasone Dipropionate Cream USP, 0.05%

68462-0300-17 Rx 0.05% 15 g Aclovate® AB

68462-0300-47 Rx 0.05% 45 g Aclovate® AB

68462-0300-65 Rx 0.05% 60 g Aclovate® AB

Alclometasone Dipropionate Ointment USP, 0.05%

68462-0299-17 Rx 0.05% 15 g Aclovate® AB

68462-0299-47 Rx 0.05% 45 g Aclovate® AB

68462-0299-65 Rx 0.05% 60 g Aclovate® AB

ALYACEN® 1/35 [Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg]

68462-0394-29 Rx 1 mg/0.035 mg 3 x 28 Ortho Novum® 1/35 AB

ALYACEN® 7/7/7 [Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg]

68462-0556-29 Rx 0.5 mg/0.035 mg 3 x 28 Ortho Novum® 7/7/7 AB

0.75 mg/0.35 mg

1 mg/0.035 mg

Aprepitant Capsules USP

68462-0583-40 Rx 40 mg 1 UD Emend® AB

68462-0583-85 Rx 40 mg 5 UD Emend® AB

68462-0584-76 Rx 80 mg 6 UD Emend® AB

68462-0584-58 Rx 80 mg 2 UOU Emend® AB [2-Day Pack]

68462-0585-76 Rx 125 mg 6 UD Emend® AB

68462-0112-33 Rx 125 mg & 80 mg 3 UOU Emend® AB [3-Day Pack]

P R O D U C T C A T A L O G

Page 4: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

P R O D U C T C A T A L O G

ASHLYNA® [Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg]

68462-0646-93 Rx 0.15 mg/0.03 mg 2 x 91 Seasonique® AB and 0.01 mg

Atomoxetine Capsules USP

68462-0265-30 Rx 10 mg 30 Strattera® AB

68462-0266-30 Rx 18 mg 30 Strattera® AB

68462-0267-30 Rx 25 mg 30 Strattera® AB

68462-0268-30 Rx 40 mg 30 Strattera® AB

68462-0269-30 Rx 60 mg 30 Strattera® AB

68462-0270-30 Rx 80 mg 30 Strattera® AB

68462-0271-30 Rx 100 mg 30 Strattera® AB

Atovaquone and Proguanil Hydrochloride Tablets

68462-0404-67 Rx 250 mg/100 mg 24 Malarone® AB

68462-0404-01 Rx 250 mg/100 mg 100 Malarone® AB

Atovaquone and Proguanil Hydrochloride Tablets [Pediatric]

68462-0402-01 Rx 62.5 mg/25 mg 100 Malarone® AB

Atovaquone Oral Suspension USP, 750 mg/5 mL

68462-0421-21 Rx 750 mg/5 mL 210 mL Mepron® AB IMAGE COMING

Azathioprine Tablets USP

68462-0502-01 Rx 50 mg 100 Imuran® AB

Azelaic Acid Gel, 15%

68462-0626-52 Rx 15% 50 gm Finacea® AB

Betamethasone Dipropionate Cream USP, 0.05% [Augmented]

68462-0290-17 Rx 0.05% 15 g Diprolene AF® AB

68462-0290-52 Rx 0.05% 50 g Diprolene AF® AB

Page 5: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

BRIELLYN® [Norethindrone and Ethinyl Estradiol Tablets USP, 0.4 mg/0.035 mg]

68462-0316-29 Rx 0.4 mg/0.035 mg 3 x 28 Ovcon® 35 AB

Calcipotriene Cream, 0.005%

68462-0501-65 Rx 0.005% 60 g Dovonex® AB

68462-0501-66 Rx 0.005% 120 g Dovonex® AB

Calcipotriene Ointment USP, 0.005%

68462-0310-65 Rx 0.005% 60 g Dovonex® AB IMAGE COMING

68462-0310-66 Rx 0.005% 120 g Dovonex® AB

Carvedilol Tablets USP

68462-0162-01 Rx 3.125 mg 100 Coreg® AB

68462-0162-05 Rx 3.125 mg 500 Coreg® AB

68462-0163-01 Rx 6.25 mg 100 Coreg® AB

68462-0163-05 Rx 6.25 mg 500 Coreg® AB

68462-0164-01 Rx 12.5 mg 100 Coreg® AB

68462-0164-05 Rx 12.5 mg 500 Coreg® AB

68462-0165-01 Rx 25 mg 100 Coreg® AB

68462-0165-05 Rx 25 mg 500 Coreg® AB

Ciclopirox Gel, 0.77%

68462-0455-35 Rx 0.77% 30 g Loprox® AB

68462-0455-47 Rx 0.77% 45 g Loprox® AB

68462-0455-94 Rx 0.77% 100 g Loprox® AB

Ciclopirox Olamine Cream USP, 0.77%

68462-0297-17 Rx 0.77% 15 g Loprox® AB

68462-0297-35 Rx 0.77% 30 g Loprox® AB

68462-0297-92 Rx 0.77% 90 g Loprox® AB

Clobetasol Propionate Cream USP, 0.05%

68462-0529-17 Rx 0.05% 15 gm Temovate® AB1

68462-0529-35 Rx 0.05% 30 gm Temovate® AB1

68462-0529-47 Rx 0.05% 45 gm Temovate® AB1

68462-0529-65 Rx 0.05% 60 gm Temovate® AB1

Clobetasol Propionate Ointment USP, 0.05%

68462-0530-17 Rx 0.05% 15 g Temovate® AB

68462-0530-35 Rx 0.05% 30 g Temovate® AB

68462-0530-47 Rx 0.05% 45 g Temovate® AB

68462-0530-65 Rx 0.05% 60 g Temovate® AB

Page 6: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Clobetasol Propionate Spray, 0.05%

68462-0480-39 Rx 0.05% 2 fl oz Clobex® AT

[59 mL]

68462-0480-56 Rx 0.05% 4.25 fl oz Clobex® AT [125 mL]

Clobetasol Propionate Topical Solution USP, 0.05%

68462-0532-28 Rx 0.05% 25 mL Temovate® | Cormax® AT

68462-0532-53 Rx 0.05% 50 mL Temovate® | Cormax® AT

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%|0.05%

68462-0298-17 Rx 1%|0.05% 15 g Lotrisone® AB

68462-0298-55 Rx 1%|0.05% 45 g Lotrisone® AB

Clotrimazole Cream USP, 1%

68462-0181-17 Rx 1% 15 g Clotrimazole Cream USP, 1% [Taro] AB

68462-0181-35 Rx 1% 30 g Clotrimazole Cream USP, 1% [Taro] AB

68462-0181-47 Rx 1% 45 g Clotrimazole Cream USP, 1% [Taro] AB

Colesevelam Hydrochloride Tablets, 625 mg

68462-0433-18 Rx 625 mg 180’s Welchol® AB

Colesevelam Hydrochloride for Oral Suspension

68462-0620-30 Rx 3.75 g 30 Packets Welchol® AB

Desmopressin Acetate Tablets

68462-0275-01 Rx 0.1 mg 100 DDAVP® AB

68462-0276-01 Rx 0.2 mg 100 DDAVP® AB

Desonide Cream, 0.05%

68462-0252-17 Rx 0.05% 15 g Desonide Cream, 0.05% [Perrigo] AB

68462-0252-65 Rx 0.05% 60 g Desonide Cream, 0.05% [Perrigo] AB [118 mL]

Desonide Lotion, 0.05%

68462-0513-39 Rx 0.05% 2 fl oz Desonide Lotion, 0.05% AB [59 mL]

68462-0513-89 Rx 0.05% 4 fl oz Desonide Lotion, 0.05% AB [118 mL]

Page 7: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Desonide Ointment, 0.05%

68462-0528-17 Rx 0.05% 15 g Desonide Ointment, 0.05% [Perrigo] AB

68462-0528-65 Rx 0.05% 60 g Desonide Ointment, 0.05% [Perrigo] AB

Desoximetasone Ointment USP, 0.25%

68462-0531-17 Rx 0.25% 15 g Topicort® AB

68462-0531-65 Rx 0.25% 60 g Topicort® AB

Diclofenac Sodium Gel, 3%

68462-0355-94 Rx 3% 100 g Solaraze® Gel, 3% AB

Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg

68462-0720-29 Rx 3 mg/0.02 mg 3 x 28 Yaz® AB

Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg

68462-0733-29 Rx 3 mg/0.03 mg 3 x 28 Yasmin® AB

Estradiol Vaginal Inserts USP, 10 mcg

68462-0711-71 Rx 10 mcg 8’s [2 x 4] Vagifem® AB

68462-0711-88 Rx 10 mcg 18’s [3 x 6] Vagifem® AB

Eszopiclone Tablets

68462-0382-01 Rx 1 mg 100 Lunesta® AB

68462-0383-01 Rx 2 mg 100 Lunesta® AB

68462-0384-01 Rx 3 mg 100 Lunesta® AB

Felodipine Extended-Release Tablets USP

68462-0233-01 Rx 2.5 mg 100 Plendil® AB

68462-0234-01 Rx 5 mg 100 Plendil® AB

68462-0235-01 Rx 10 mg 100 Plendil® AB

Page 8: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Fenofibrate Capsules USP [Micronized]

68462-0580-01 Rx 67 mg 100 Tricor® | Lofibra® AB

68462-0581-01 Rx 134 mg 100 Tricor® | Lofibra® AB

68462-0582-01 Rx 200 mg 100 Tricor® | Lofibra® AB

Fluconazole Tablets USP

68462-0101-30 Rx 50 mg 30 Diflucan® AB

68462-0102-30 Rx 100 mg 30 Diflucan® AB

68462-0103-40 Rx 150 mg 12 Diflucan® AB

68462-0104-30 Rx 200 mg 30 Diflucan® AB

Fluocinolone Acetonide Oil, 0.01% (Ear Drops)

68462-0185-56 Rx 0.01% 1 fl oz [20 mL] DermOtic® AT IMAGE COMING

Fluocinolone Acetonide Topical Oil, 0.01% [Body Oil]

68462-0591-89 Rx 0.01% 118 mL Derma-Smoothe/FS® AT

Fluocinolone Acetonide Topical Oil, 0.01% [Scalp Oil]

68462-0590-89 Rx 0.01% 118 mL Derma-Smoothe/FS® AT

Fluocinonide Cream USP, 0.1%

68462-0505-35 Rx 0.1% 30 g Vanos® AB

68462-0505-65 Rx 0.1% 60 g Vanos® AB

68462-0505-66 Rx 0.1% 120 g Vanos® AB

Fluticasone Propionate Lotion USP

68462-0427-02 Rx 0.05% 60 Cutivate® AB

Page 9: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Fosinopril Sodium/HCTZ Tablets

68462-0554-01 Rx 10 mg/12.5 mg 100 Monopril HCT® AB

68462-0555-01 Rx 20 mg/12.5 mg 100 Monopril HCT® AB

Frovatriptan Succinate Tablets, 2.5 mg

68462-0694-97 Rx 2.5 mg 9 Frova® AB

Gabapentin Tablets USP

68462-0126-01 Rx 600 mg 100 Neurontin® AB

68462-0126-05 Rx 600 mg 500 Neurontin® AB

68462-0127-01 Rx 800 mg 100 Neurontin® AB

68462-0127-05 Rx 800 mg 500 Neurontin® AB

HAILEY® 24 Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 mg/20 mcg

68462-0731-29 Rx 1 mg/20 mcg 3 x 28 Loestrin® 24 Fe AB

HEATHER® [Norethindrone Tablets USP, 0.35 mg]

68462-0303-29 Rx 0.35 mg 3 x 28 Nor-QD® AB

Hydrocortisone Butyrate Cream, 0.1% [Lipophilic]

68462-0464-47 Rx 0.1% 45 g Locoid Lipocream® AB

68462-0464-65 Rx 0.1% 60 g Locoid Lipocream® AB

Hydrocortisone Valerate Cream USP, 0.2%

68462-0575-17 Rx 0.2% 15 g Westcort® AB

68462-0575-47 Rx 0.2% 45 g Westcort® AB

68462-0575-65 Rx 0.2% 60 g Westcort® AB

Hydrocortisone Valerate Ointment USP, 0.2%

68462-0836-17 Rx 0.2% 15 g Westcort® AB

68462-0836-47 Rx 0.2% 45 g Westcort® AB IMAGE COMING

68462-0836-65 Rx 0.2% 60 g Westcort® AB

Imiquimod Cream

68462-0536-70 Rx 5% 0.25 g x 24 Aldara® AB

Page 10: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Indomethacin Capsules USP

68462-0406-01 Rx 25 mg 100 Indomethacin Capsules [Mylan] AB

68462-0406-10 Rx 25 mg 1000 Indomethacin Capsules [Mylan] AB

68462-0302-01 Rx 50 mg 100 Indomethacin Capsules [Mylan] AB

68462-0302-05 Rx 50 mg 500 Indomethacin Capsules [Mylan] AB

Indomethacin Extended-Release Capsules USP, 75 mg

68462-0325-60 Rx 75 mg 60 Indocin® SR AB

68462-0325-90 Rx 75 mg 90 Indocin® SR AB

68462-0325-01 Rx 75 mg 100 Indocin® SR AB

Lamotrigine Tablets [Chewable, Dispersible]

68462-0228-01 Rx 5 mg 100 Lamictal CD® AB

68462-0229-01 Rx 25 mg 100 Lamictal CD® AB

Levocetirizine Dihydrochloride Tablets

68462-0346-90 Rx 5 mg 90 Xyzal® AB

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.09 mg/0.02 mg

68462-0637-29 Rx 0.09 mg/0.02 mg 3 x 28 Lybrel® AB

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg

68462-0672-95 Rx 0.15 mg/0.03 mg 3 x 91 Seasonale® AB

Lidocaine Ointment USP, 5%

68462-0418-20 Rx 5% 35.44 g Lidocaine Ointment USP, 5% AT [Fougera]

68462-0418-27 Rx 5% 50 g [Jar] Lidocaine Ointment USP, 5% AT

[Fougera]

Lithium Carbonate Capsules USP

68462-0220-01 Rx 150 mg 100 Lithium Carbonate Capsules [Roxane] AB

68462-0221-01 Rx 300 mg 100 Lithium Carbonate Capsules [Roxane] AB

68462-0221-10 Rx 300 mg 1000 Lithium Carbonate Capsules [Roxane] AB

68462-0222-01 Rx 600 mg 100 Lithium Carbonate Capsules [Roxane] AB

Page 11: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Lithium Carbonate Extended-Release Tablets USP [300 mg]

68462-0223-01 Rx 300 mg 100 Lithobid® AB

Lithium Carbonate Extended-Release Tablets USP [450 mg]

68462-0224-01 Rx 450 mg 100 Lithium Carbonate Extended-Release AB Tablets USP, 450 mg [Roxane]

MARLISSA® [Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg]

68462-0388-29 Rx 0.15 mg/0.03 mg 3 x 28 Nordette® AB

Methadone Hydrochloride Tablets USP

68462-0800-01 Rx 5 mg 100 Dolophine® AA

68462-0801-01 Rx 10 mg 100 Dolophine® AA

Moexipril Hydrochloride Tablets USP

68462-0209-01 Rx 7.5 mg 100 Univasc® AB

68462-0208-01 Rx 15 mg 100 Univasc® AB

Mometasone Furoate Cream USP, 0.1%

68462-0192-17 Rx 0.1% 15 g Elocon® AB

68462-0192-55 Rx 0.1% 45 g Elocon® AB

Mometasone Furoate Ointment USP, 0.1%

68462-0225-17 Rx 0.1% 15 g Elocon® AB

68462-0225-55 Rx 0.1% 45 g Elocon® AB

Mupirocin Cream USP, 2%

68462-0564-17 Rx 2% 15 g Bactroban® AB

68462-0564-35 Rx 2% 30 g Bactroban® AB

Mupirocin Ointment USP, 2%

68462-0180-22 Rx 2% 22 g Bactroban® AB

Nabumetone Tablets USP

68462-0358-01 Rx 500 mg 100 Relafen® AB

68462-0358-05 Rx 500 mg 500 Relafen® AB

68462-0359-01 Rx 750 mg 100 Relafen® AB

68462-0359-05 Rx 750 mg 500 Relafen® AB

Page 12: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Naproxen Sodium Tablets USP

68462-0178-01 Rx 275 mg 100 Anaprox® | DS AB

68462-0178-05 Rx 275 mg 500 Anaprox® | DS AB

68462-0179-01 Rx 550 mg 100 Anaprox® | DS AB

68462-0179-05 Rx 550 mg 500 Anaprox® | DS AB

Naproxen Tablets USP

68462-0188-01 Rx 250 mg 100 Naprosyn® AB

68462-0188-05 Rx 250 mg 500 Naprosyn® AB

68462-0189-01 Rx 375 mg 100 Naprosyn® AB

68462-0189-05 Rx 375 mg 500 Naprosyn® AB

68462-0190-30 Rx 500 mg 30 Naprosyn® AB

68462-0190-50 Rx 500 mg 50 Naprosyn® AB

68462-0190-01 Rx 500 mg 100 Naprosyn® AB

68462-0190-05 Rx 500 mg 500 Naprosyn® AB

Nitroglycerin Sublingual Tablets USP

68462-0638-01 Rx 0.3 mg 100 Nitrostat® AB

68462-0639-01 Rx 0.4 mg 100 Nitrostat® AB

68462-0639-45 Rx 0.4 mg 4 x 25 Bottles Nitrostat® AB

68462-0640-01 Rx 0.6 mg 100 Nitrostat® AB

Nizatidine Capsules USP

68462-0425-60 Rx 150 mg 60 Axid® AB

68462-0426-30 Rx 300 mg 30 Axid® AB

Norethindrone Acetate Tablets USP

68462-0304-50 Rx 5 mg 50 Aygestin® AB

Norethindrone Tablets USP, 0.35 mg

68462-0305-29 Rx 0.35 mg 3 x 28 Ortho Micronor® AB

Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg

68462-0656-29 Rx 0.5 mg/2.5 mcg 3 x 28 FemHRT® AB

Page 13: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/5 mcg

68462-0657-29 Rx 1 mg/5 mcg 3 x 28 FemHRT® AB

68462-0657-90 Rx 1 mg/5 mcg 90 FemHRT® AB

Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg

68462-0132-81 Rx 1 mg/0.02 mg 3 x 21 Loestrin® 21 1/20 AB

Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets, 1 mg/20 mcg

68462-0376-29 Rx 1 mg/20 mcg 3 x 28 Minastrin® 24 Fe AB and 75 mg

Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, 0.25 mg/0.025 mg

68462-0719-29 Rx 0.18 mg/0.025 mg 3 x 28 Ortho Tri-Cyclen® Lo AB

0.215 mg/0.025 mg 0.25 mg/0.025 mg

Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg

68462-0565-29 Rx 0.18 mg/0.035 mg 3 x 28 Ortho Tri-Cyclen® AB

0.215 mg/0.035 mg 0.25 mg/0.035 mg

Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg

68462-0309-29 Rx 0.25 mg/0.035 mg 3 x 28 Ortho Cyclen® AB

Nystatin and Triamcinolone Acetonide Cream USP

68462-0314-17 Rx 100,000 units/gram 15 g Nystatin and Triamcinolone AT and 1 mg/g Acetonide Cream USP [Taro]

68462-0314-35 Rx 100,000 units/gram 30 g Nystatin and Triamcinolone AT and 1 mg/g Acetonide Cream USP [Taro]

68462-0314-65 Rx 100,000 units/gram 60 g Nystatin and Triamcinolone AT and 1 mg/g Acetonide Cream USP [Taro]

Nystatin and Triamcinolone Acetonide Ointment USP

68462-0799-17 Rx 100,000 units/1 mg 15 g Nystatin and Triamcinolone AT Per Gram Acetonide Ointment USP [Taro]

68462-0799-35 Rx 100,000 units/1 mg 30 g Nystatin and Triamcinolone AT

Per Gram Acetonide Ointment USP [Taro]

68462-0799-65 Rx 100,000 units/1 mg 60 g Nystatin and Triamcinolone AT Per Gram Acetonide Ointment USP [Taro]

Page 14: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Olmesartan Medoxomil Tablets

68462-0436-30 Rx 5 mg 30 Benicar® AB

68462-0437-30 Rx 20 mg 30 Benicar® AB

68462-0437-90 Rx 20 mg 90 Benicar® AB

68462-0438-30 Rx 40 mg 30 Benicar® AB

68462-0438-90 Rx 40 mg 90 Benicar® AB

Omeprazole Delayed-Release Capsules USP*

68462-0395-30 Rx 10 mg 30 Prilosec® AB

68462-0395-90 Rx 10 mg 90 Prilosec® AB 68462-0395-01 Rx 10 mg 100 Prilosec® AB

68462-0395-10 Rx 10 mg 1000 Prilosec® AB

68462-0396-30 Rx 20 mg 30 Prilosec® AB

68462-0396-90 Rx 20 mg 90 Prilosec® AB 68462-0396-01 Rx 20 mg 100 Prilosec® AB

68462-0396-10 Rx 20 mg 1000 Prilosec® AB

68462-0397-30 Rx 40 mg 30 Prilosec® AB

68462-0397-90 Rx 40 mg 90 Prilosec® AB 68462-0397-01 Rx 40 mg 100 Prilosec® AB

68462-0397-10 Rx 40 mg 1000 Prilosec® AB*Please see the Omeprazole Delayed-Release Capsules USP product details page at www.glenmarkpharma.com/usa for an Important Product Announcement

Ondansetron Orally Disintegrating Tablets USP

68462-0157-13 Rx 4 mg 30 Zofran ODT® AB

68462-0158-11 Rx 8 mg 10 Zofran ODT® AB

68462-0158-13 Rx 8 mg 30 Zofran ODT® AB

Ondansetron Tablets USP

68462-0105-30 Rx 4 mg 30 Zofran® AB

68462-0106-30 Rx 8 mg 30 Zofran® AB

Oxcarbazepine Tablets USP

68462-0137-01 Rx 150 mg 100 Trileptal® AB

68462-0138-01 Rx 300 mg 100 Trileptal® AB

68462-0139-01 Rx 600 mg 100 Trileptal® AB

Page 15: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Oxycodone Hydrochloride Capsules

68462-0204-01 Rx 5 mg 100 n/a n/a

Oxycodone Hydrochloride Oral Solution [20 mg/mL]

68462-0347-37 Rx 20 mg/mL 30 mL n/a n/a

Phendimetrazine Tartrate Tablets USP

68462-0561-01 Rx 35 mg 100 Bontril® PDM AA

68462-0561-10 Rx 35 mg 1000 Bontril® PDM AA

Potassium Chloride Extended-Release Capsules USP

68462-0357-01 Rx 750 mg [10 mEq K] 100 Potassium Chloride Extended-Release AB Capsules USP [Actavis]

68462-0357-05 Rx 750 mg [10 mEq K] 500 Potassium Chloride Extended-Release AB Capsules USP [Actavis]Potassium Chloride Extended-Release Tablets USP

68462-0471-01 Rx 10 mEq K [750 mg] 100 Klor-Kon® M10 AB

68462-0472-01 Rx 20 mEq K [1500 mg] 100 Klor-Kon® M20 AB

68462-0472-05 Rx 20 mEq K [1500 mg] 500 Klor-Kon® M20 AB

Pramipexole Dihydrochloride Tablets

68462-0330-90 Rx 0.125 mg 90 Mirapex® AB

68462-0331-90 Rx 0.25 mg 90 Mirapex® AB

68462-0332-90 Rx 0.5 mg 90 Mirapex® AB

68462-0333-90 Rx 1 mg 90 Mirapex® AB

68462-0334-90 Rx 1.5 mg 90 Mirapex® AB

Pravastatin Sodium Tablets USP

68462-0195-90 Rx 10 mg 90 Pravachol® AB

68462-0195-05 Rx 10 mg 500 Pravachol® AB

68462-0196-90 Rx 20 mg 90 Pravachol® AB

68462-0196-05 Rx 20 mg 500 Pravachol® AB

68462-0197-90 Rx 40 mg 90 Pravachol® AB

68462-0197-05 Rx 40 mg 500 Pravachol® AB

68462-0198-90 Rx 80 mg 90 Pravachol® AB

68462-0198-05 Rx 80 mg 500 Pravachol® AB

Page 16: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Propafenone Hydrochloride Extended-Release Capsules USP

68462-0408-60 Rx 225 mg 60 Rythmol® SR AB

68462-0409-60 Rx 325 mg 60 Rythmol® SR AB

68462-0410-60 Rx 425 mg 60 Rythmol® SR AB

Raloxifene Hydrochloride Tablets USP

68462-0393-30 Rx 60 mg 30 Evista® AB

Ranitidine Tablets USP

68462-0248-60 Rx 150 mg 60 Zantac® AB

68462-0248-01 Rx 150 mg 100 Zantac® AB

68462-0248-05 Rx 150 mg 500 Zantac® AB

68462-0249-30 Rx 300 mg 30 Zantac® AB

68462-0249-01 Rx 300 mg 100 Zantac® AB

68462-0249-20 Rx 300 mg 250 Zantac® AB

Riluzole Tablets USP

68462-0381-60 Rx 50 mg 60 Rilutek® AB

Rizatriptan Benzoate Orally Disintegrating Tablets USP

68462-0467-06 Rx 5 mg 18 Maxalt MLT® AB

68462-0468-06 Rx 10 mg 18 Maxalt MLT® AB

Rizatriptan Benzoate Tablets

68462-0465-99 Rx 5 mg 18 Maxalt® AB

68462-0466-99 Rx 10 mg 18 Maxalt® AB

Page 17: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

16

P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

ROPINIRole Tablets USP

68462-0253-01 Rx 0.25 mg 100 Requip® AB

68462-0254-01 Rx 0.5 mg 100 Requip® AB

68462-0255-01 Rx 1 mg 100 Requip® AB

68462-0256-01 Rx 2 mg 100 Requip® AB

68462-0257-01 Rx 3 mg 100 Requip® AB

68462-0258-01 Rx 4 mg 100 Requip® AB

68462-0259-01 Rx 5 mg 100 Requip® AB

Rosuvastatin Calcium Tablets

68462-0261-90 Rx 5 mg 90 Crestor® AB

68462-0262-90 Rx 10 mg 90 Crestor® AB

68462-0263-90 Rx 20 mg 90 Crestor® AB

68462-0264-30 Rx 40 mg 30 Crestor® AB

Sevelamer Hydrochloride Tablets

68462-0446-26 Rx 400 mg 360 Renagel® AB IMAGE COMING

68462-0447-18 Rx 800 mg 180 Renagel® AB IMAGE COMING

Tacrolimus Ointment, 0.1%

68462-0534-35 Rx 0.1% 30 g Protopic® AB

68462-0534-65 Rx 0.1% 60 g Protopic® AB

68462-0534-94 Rx 0.1% 100 g Protopic® AB

Telmisartan Tablets USP

68462-0199-13 Rx 20 mg 30 Micardis® AB

68462-0200-13 Rx 40 mg 30 Micardis® AB

68462-0201-13 Rx 80 mg 30 Micardis® AB

Page 18: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

17

P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Topiramate Tablets USP

68462-0108-60 Rx 25 mg 60 Topamax® AB

68462-0108-10 Rx 25 mg 1000 Topamax® AB

68462-0153-60 Rx 50 mg 60 Topamax® AB

68462-0153-10 Rx 50 mg 1000 Topamax® AB

68462-0109-60 Rx 100 mg 60 Topamax® AB

68462-0109-10 Rx 100 mg 1000 Topamax® AB

68462-0110-60 Rx 200 mg 60 Topamax® AB

68462-0110-10 Rx 200 mg 1000 Topamax® AB

Trandolapril and Verapamil Hydrochloride Extended-Release Tablets

68462-0294-01 Rx 1 mg/240 mg 100 Tarka® AB

68462-0295-01 Rx 2 mg/180 mg 100 Tarka® AB

68462-0296-01 Rx 2 mg/240 mg 100 Tarka® AB

68462-0329-01 Rx 4 mg/240 mg 100 Tarka® AB

Tretinoin Capsules

68462-0792-01 Rx 10 mg 100 Vesanoid® AB

Triamcinolone Acetonide Cream USP, 0.1%

68462-0131-17 Rx 0.1% 15 g Triamcinolone Acetonide Cream AT USP, 0.1% [Fougera]

68462-0131-35 Rx 0.1% 30 g Triamcinolone Acetonide Cream AT USP, 0.1% [Fougera]

68462-0131-49 Rx 0.1% 80 g Triamcinolone Acetonide Cream AT USP, 0.1% [Fougera]

68462-0131-59 Rx 0.1% 454 g Triamcinolone Acetonide Cream AT USP, 0.1% [Fougera]

Triamcinolone Acetonide Ointment USP, 0.5%

68462-0798-17 Rx 0.5% 15 g Triamcinolone Acetonide AT Ointment USP, 0.5% [Perrigo]

Trospium Chloride Tablets USP

68462-0461-60 Rx 20 mg 60 Sanctura® AB

68462-0461-10 RX 20 mg 1000 Sanctura® AB

Ursodiol Tablets USP

68462-0473-01 Rx 250 mg 100 Urso 250® AB

68462-0474-01 Rx 500 mg 100 Urso Forte® AB

Page 19: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

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P R O D U C T C A T A L O G

NDC OTC/Rx Strength Size Reference Brand TE Code Product Image [Not to Scale]

Verapamil Hydrochloride Extended-Release Tablets USP

68462-0292-01 Rx 120 mg 100 Isoptin® SR AB

68462-0293-01 Rx 180 mg 100 Isoptin® SR AB

68462-0293-05 Rx 180 mg 500 Isoptin® SR AB

68462-0260-01 Rx 240 mg 100 Isoptin® SR AB

68462-0260-05 Rx 240 mg 500 Isoptin® SR AB

VIORELE® [Desogestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.02 mg and Ethinyl Estradiol Tablets USP, 0.01 mg]

68462-0318-29 Rx 0.15 mg/0.02 mg 3 x 28 Mircette® AB and 0.01 mg

Voriconazole Tablets

68462-0572-30 Rx 50 mg 30 Vfend® AB

68462-0573-30 Rx 200 mg 30 Vfend® AB

Zolmitriptan Orally Disintegrating Tablets

68462-0499-76 Rx 2.5 mg 6 Zomig-ZMT® AB

68462-0500-33 Rx 5 mg 3 Zomig-ZMT® AB

Zolmitriptan Tablets

68462-0497-76 Rx 2.5 mg 6 Zomig® AB

68462-0498-33 Rx 5 mg 3 Zomig® AB

Zonisamide Capsules USP

68462-0128-01 Rx 25 mg 100 Zonegran® AB

68462-0129-01 Rx 50 mg 100 Zonegran® AB

68462-0130-01 Rx 100 mg 100 Zonegran® AB

68462-0130-05 Rx 100 mg 500 Zonegran® AB

Page 20: U.S. PRODUCT CATALOG...MARCH 2019 U.S. PRODUCT CATALOG NEW PRODUCTS: SEVELAMER HYDROCHLORIDE TABLETS, 400 MG AND 800 MG FLUOCINOLONE ACETONIDE OIL, 0.01% (EAR DROPS) HYDROCORTISONE

Glenmark Pharmaceuticals Inc., USA750 Corporate Drive, Mahwah, NJ 07430

www.glenmarkpharma-us.comGLN-03-16-002