Tetrabenazine
These highlights do not include all the information needed to use TETRABENAZINE TABLETS safely and effectively. See full prescribing information for TETRABENAZINE TABLETS. TETRABENAZINE tablets, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
a03c3cf8-fcd4-4dbf-a4f5-59bd7887c902
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2018
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tetrabenazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-821
Application NumberANDA204574
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tetrabenazine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2018
FDA Product Classification
INGREDIENTS (5)
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TETRABENAZINEActive
Quantity: 12.5 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Tetrabenazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-822
Application NumberANDA204574
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tetrabenazine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2018
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TETRABENAZINEActive
Quantity: 25 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT