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
acf78d97-fca5-49aa-8683-6db7396da72f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
Bionpharma Inc.
DUNS: 079637826
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 Code69452-117
Application NumberANDA208826
Product Classification
M
Marketing Category
C73584
G
Generic Name
TETRABENAZINE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (7)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TETRABENAZINEActive
Quantity: 12.5 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TETRABENAZINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69452-118
Application NumberANDA208826
Product Classification
M
Marketing Category
C73584
G
Generic Name
TETRABENAZINE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TETRABENAZINEActive
Quantity: 25 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB