GABAPENTIN- gabapentin tablet 
Zydus Lifesciences Limited

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Gabapentin Tablets

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

gabapentin 300 mg

NDC 70771-1862-9 in bottle of 90 tablets

Gabapentin tablets, 600 mg

Rx only

90 tablets

gabapentin 600 mg

gabapentin 600 mg

GABAPENTIN 
gabapentin tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1861
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN300 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVALSize17mm
FlavorImprint Code 608
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1861-990 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2024
2NDC:70771-1861-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2024
3NDC:70771-1861-210 in 1 BLISTER PACK; Type 0: Not a Combination Product01/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20393401/25/2024
GABAPENTIN 
gabapentin tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1862
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN600 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVALSize19mm
FlavorImprint Code 607
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1862-990 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2024
2NDC:70771-1862-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2024
3NDC:70771-1862-410 in 1 CARTON01/25/2024
3NDC:70771-1862-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20393401/25/2024
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1861, 70771-1862) , MANUFACTURE(70771-1861, 70771-1862)

Revised: 1/2024
Document Id: dddcb2cc-bb94-4f75-87ed-f7bf8c5db9b3
Set id: 8c0eeefc-ef5b-49f4-8411-ddbae312ed05
Version: 1
Effective Time: 20240125
 
Zydus Lifesciences Limited