Gabapentin
Gabapentin Capsules, USP
Approved
Approval ID
99adb2c7-4725-4768-a2d9-856a87f33192
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 3, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
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 Code52959-757
Application NumberANDA090705
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2012
FDA Product Classification
INGREDIENTS (7)
GABAPENTINActive
Quantity: 100 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT