GABAPENTIN- gabapentin tablet, film coated 
Cadila Healthcare Limited

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GABAPENTIN TABLETS

Manufactured by:

Cadila Heathcare Ltd.

India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-705-01 in bottle of 100 tablets

Gabapentin Tablets USP, 600 mg

Rx only

100 tablets

Gabapentin tablets

NDC 65841-706-01 in bottle of 100 tablets

Gabapentin Tablets USP, 800 mg

Rx only

100 tablets

Gabapentin tablets
GABAPENTIN 
gabapentin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-705
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN600 mg
Inactive Ingredients
Ingredient NameStrength
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size17mm
FlavorImprint Code ZE72
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-705-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
2NDC:65841-705-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
3NDC:65841-705-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07892610/16/2012
GABAPENTIN 
gabapentin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-706
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN800 mg
Inactive Ingredients
Ingredient NameStrength
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size20mm
FlavorImprint Code ZE71
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-706-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
2NDC:65841-706-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
3NDC:65841-706-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/16/2012
4NDC:65841-706-7710 in 1 CARTON10/16/2012
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07892610/16/2012
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-705, 65841-706) , MANUFACTURE(65841-705, 65841-706)

Revised: 8/2020
Document Id: d11bfb82-7bea-4ebe-9a82-ac79e6ac7537
Set id: b033c169-4943-4ad9-ace0-7e4a1f0dc100
Version: 5
Effective Time: 20200826
 
Cadila Healthcare Limited