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

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 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 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 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)