Gabapentin
Gabapentin Tablets, USP 600 mg and 800 mg Allied Pharma Inc
Approved
Approval ID
636f4f87-7a1a-4d02-a9e5-f0cec260513c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2013
Manufacturers
FDA
Allied Pharma Inc
DUNS: 965727683
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76267-151
Application NumberANDA203244
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2012
FDA Product Classification
INGREDIENTS (11)
gabapentinActive
Quantity: 800 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
Gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76267-150
Application NumberANDA203244
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2012
FDA Product Classification
INGREDIENTS (11)
gabapentinActive
Quantity: 600 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT