Gabapentin
Gabapentin Capsules, USP
Approved
Approval ID
7e351770-8975-4417-a599-feaa3cba7514
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2010
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
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 Code10544-185
Application NumberANDA078787
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2010
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GABAPENTINActive
Quantity: 100 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT