gabapentin by Zydus Lifesciences Limited GABAPENTIN tablet

gabapentin by

Drug Labeling and Warnings

gabapentin by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED

SPL MEDGUIDE

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

INGREDIENTS AND APPEARANCE

GABAPENTIN 
gabapentin tablet

Product 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 tablet

Product 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 tablet

Product 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 tablet

Product 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 tablet

Product 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)