GABAPENTIN
GABAPENTIN TABLETS USPRx only44434444
Approved
Approval ID
998dcd24-c6f0-463c-9d13-e5c72b0e8fa0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code42549-537
Application NumberANDA076017
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2012
FDA Product Classification
INGREDIENTS (4)
GABAPENTINActive
Quantity: 600 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT