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
aca55884-1eb4-4a76-8c7f-96c782849337
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2023
Manufacturers
FDA
Precision Dose Inc.
DUNS: 035886746
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 Code68094-805
Application NumberANDA207682
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 31, 2023
Generic NameTETRABENAZINE
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TETRABENAZINEActive
Quantity: 25 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TETRABENAZINE
PRODUCT DETAILS
NDC Product Code68094-905
Application NumberANDA207682
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 31, 2023
Generic NameTETRABENAZINE
INGREDIENTS (5)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
TETRABENAZINEActive
Quantity: 12.5 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT