Felbamate
Felbamate Tablets, USP (400 mg and 600 mg)
Approved
Approval ID
1aa40de5-c02d-49d6-8722-ed88c40c3ba6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Felbamate
PRODUCT DETAILS
NDC Product Code53746-734
Application NumberANDA201680
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 31, 2023
Generic NameFelbamate
INGREDIENTS (8)
FELBAMATEActive
Quantity: 400 mg in 1 1
Code: X72RBB02N8
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Felbamate
PRODUCT DETAILS
NDC Product Code53746-735
Application NumberANDA201680
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 31, 2023
Generic NameFelbamate
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FELBAMATEActive
Quantity: 600 mg in 1 1
Code: X72RBB02N8
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT