Gabapentin
These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
Approved
Approval ID
1045db4e-4c76-4a0d-bf12-019bd96a8f59
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2023
Manufacturers
FDA
Radha Pharmaceuticals, Inc.
DUNS: 117634222
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 Code77771-177
Application NumberANDA205101
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (12)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
GABAPENTINActive
Quantity: 600 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
Gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code77771-178
Application NumberANDA205101
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (12)
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GABAPENTINActive
Quantity: 800 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT