GABAPENTIN
Gabapentin Tablets, USP
Approved
Approval ID
697071e0-f051-46c6-8b02-9131be9d4d28
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2010
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 Code16590-104
Application NumberANDA077525
Product Classification
M
Marketing Category
C73584
G
Generic Name
GABAPENTIN
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2010
FDA Product Classification
INGREDIENTS (12)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GABAPENTINActive
Quantity: 800 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
GLYCERYL BEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT