Label: GABAPENTIN tablet
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NDC Code(s):
70771-1861-2,
70771-1861-5,
70771-1861-9,
70771-1862-2, view more70771-1862-4, 70771-1862-5, 70771-1862-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 25, 2024
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INGREDIENTS AND APPEARANCE
GABAPENTIN
gabapentin tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1861 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 300 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) COPOVIDONE K25-31 (UNII: D9C330MD8B) HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYETHYLENE GLYCOL 7000000 (UNII: G3MS6M810Y) POVIDONE K90 (UNII: RDH86HJV5Z) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL Size 17mm Flavor Imprint Code 608 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1861-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2024 2 NDC:70771-1861-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2024 3 NDC:70771-1861-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/25/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203934 01/25/2024 GABAPENTIN
gabapentin tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1862 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 600 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) COPOVIDONE K25-31 (UNII: D9C330MD8B) HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYETHYLENE GLYCOL 7000000 (UNII: G3MS6M810Y) POVIDONE K90 (UNII: RDH86HJV5Z) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL Size 19mm Flavor Imprint Code 607 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1862-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2024 2 NDC:70771-1862-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2024 3 NDC:70771-1862-4 10 in 1 CARTON 01/25/2024 3 NDC:70771-1862-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203934 01/25/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1861, 70771-1862) , MANUFACTURE(70771-1861, 70771-1862)
