Felbamate
Felbamate Tablets USP 400 mg and 600 mg
Approved
Approval ID
f2edb3ed-da20-4093-88ea-00fe781e47e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., inc.
DUNS: 145186370
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Felbamate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4186
Application NumberANDA207093
Product Classification
M
Marketing Category
C73584
G
Generic Name
Felbamate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FELBAMATEActive
Quantity: 600 mg in 1 1
Code: X72RBB02N8
Classification: ACTIB
Felbamate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4185
Application NumberANDA207093
Product Classification
M
Marketing Category
C73584
G
Generic Name
Felbamate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FELBAMATEActive
Quantity: 400 mg in 1 1
Code: X72RBB02N8
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT