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 useInitial U.S. Approval: 2008
Approved
Approval ID
b041d7a5-a678-4f80-8d78-a42d3d003fbc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2019
Manufacturers
FDA
TAGI Pharma, Inc.
DUNS: 963322560
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TETRABENAZINE
PRODUCT DETAILS
NDC Product Code51224-425
Application NumberANDA207682
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 30, 2019
Generic NameTETRABENAZINE
INGREDIENTS (5)
TETRABENAZINEActive
Quantity: 12.5 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TETRABENAZINE
PRODUCT DETAILS
NDC Product Code51224-426
Application NumberANDA207682
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 30, 2019
Generic NameTETRABENAZINE
INGREDIENTS (6)
TETRABENAZINEActive
Quantity: 25 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT