Gabapentin
Approved
Approval ID
06f5461f-0a34-42e1-b84a-567ffafd8e99
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2010
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
Products 2
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 Code67046-223
Application NumberANDA078428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2010
FDA Product Classification
INGREDIENTS (1)
GABAPENTINActive
Quantity: 400 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
Gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-224
Application NumberANDA078428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2010
FDA Product Classification
INGREDIENTS (4)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GABAPENTINActive
Quantity: 300 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT