Label: ABACAVIR AND LAMIVUDINE tablet, film coated
- NDC Code(s): 70771-1053-3, 70771-1053-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 27, 2023
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INGREDIENTS AND APPEARANCE
ABACAVIR AND LAMIVUDINE
abacavir and lamivudine tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1053 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS) ABACAVIR 600 mg LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95) LAMIVUDINE 300 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE K30 (UNII: U725QWY32X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (LIGHT YELLOW TO YELLOW) Score no score Shape CAPSULE (CAPSULE) Size 20mm Flavor Imprint Code 1049 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1053-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2019 2 NDC:70771-1053-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208990 03/14/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1053) , MANUFACTURE(70771-1053)
