GABAPENTIN
Gabapentin Capsules, USP
Approved
Approval ID
249e184c-8996-4206-8ee3-b6faa46d3188
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2009
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
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 Code64725-0138
Application NumberANDA077242
Product Classification
M
Marketing Category
C73584
G
Generic Name
GABAPENTIN
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2009
FDA Product Classification
INGREDIENTS (9)
GABAPENTINActive
Quantity: 300 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT