Gabapentin
Gabapentin Capsules
Approved
Approval ID
d08562ff-7ebf-4669-a824-933bf66b6328
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2011
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
Products 3
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 Code68387-410
Application NumberANDA078428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2011
FDA Product Classification
INGREDIENTS (1)
GABAPENTINActive
Quantity: 300 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
Gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68387-420
Application NumberANDA078428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2011
FDA Product Classification
INGREDIENTS (1)
GABAPENTINActive
Quantity: 100 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
Gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68387-404
Application NumberANDA078428
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2011
FDA Product Classification
INGREDIENTS (1)
GABAPENTINActive
Quantity: 400 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB