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, 70771-1916-1, 70771-1916-6, 70771-1917-1, 70771-1917-6, 70771-1918-1, 70771-1918-6
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 15, 2025
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1861-9 in bottle of 90 tablets
Gabapentin tablets, 300 mg
Rx only
90 tablets
gabapentin 300 mg
NDC 70771-1862-9 in bottle of 90 tablets
Gabapentin tablets, 600 mg
Rx only
90 tablets
gabapentin 600 mg
NDC 70771-1916-6 in bottle of 60 tablets
Gabapentin tablets, 450 mg
Rx only
60 tablets
NDC 70771-1917-6 in bottle of 60 tablets
Gabapentin tablets, 750 mg
Rx only
60 tablets
NDC 70771-1918-6 in bottle of 60 tablets
Gabapentin tablets, 900 mg
Rx only
60 tablets
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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, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) 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, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) 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 GABAPENTIN
gabapentin tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1916 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 450 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) COPOVIDONE K25-31 (UNII: D9C330MD8B) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) 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 355 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1916-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 09/18/2025 2 NDC:70771-1916-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/18/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203934 09/18/2025 GABAPENTIN
gabapentin tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1917 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 750 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) COPOVIDONE K25-31 (UNII: D9C330MD8B) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) 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 356 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1917-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 09/18/2025 2 NDC:70771-1917-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/18/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203934 09/18/2025 GABAPENTIN
gabapentin tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1918 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 900 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) COPOVIDONE K25-31 (UNII: D9C330MD8B) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL Size 20mm Flavor Imprint Code 357 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1918-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 09/18/2025 2 NDC:70771-1918-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/18/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203934 09/18/2025 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) Establishment Name Address ID/FEI Business Operations Zydus Pharmaceuticals Limited 650173735 MANUFACTURE(70771-1916, 70771-1917, 70771-1918) , ANALYSIS(70771-1916, 70771-1917, 70771-1918)