GABAPENTIN
GABAPENTIN
Approved
Approval ID
2e319a08-901d-40a9-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 11, 2019
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 3
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 Code61919-350
Application NumberANDA077662
Product Classification
M
Marketing Category
C73584
G
Generic Name
GABAPENTIN
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2019
FDA Product Classification
INGREDIENTS (11)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
GABAPENTINActive
Quantity: 800 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GABAPENTIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-661
Application NumberANDA204989
Product Classification
M
Marketing Category
C73584
G
Generic Name
GABAPENTIN
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2019
FDA Product Classification
INGREDIENTS (6)
GABAPENTINActive
Quantity: 100 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GABAPENTIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-417
Application NumberANDA090705
Product Classification
M
Marketing Category
C73584
G
Generic Name
GABAPENTIN
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2019
FDA Product Classification
INGREDIENTS (7)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GABAPENTINActive
Quantity: 300 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT