Gabapentin
These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, USP, for oral use Initial U.S. Approval: 1993
Approved
Approval ID
c77abf60-4ee5-44cf-a518-723ffd4c2dcb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2017
Manufacturers
FDA
Avera McKennan Hospital
DUNS: 068647668
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 Code69189-0614
Application NumberANDA078428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2017
FDA Product Classification
INGREDIENTS (2)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GABAPENTINActive
Quantity: 100 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB