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
471ac1d8-e3ad-7729-87c5-c26ae92c32eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
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 Code60505-3883
Application NumberANDA206093
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 5, 2023
Generic Nametetrabenazine
INGREDIENTS (6)
TETRABENAZINEActive
Quantity: 25 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
tetrabenazine
PRODUCT DETAILS
NDC Product Code60505-3882
Application NumberANDA206093
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 5, 2023
Generic Nametetrabenazine
INGREDIENTS (5)
TETRABENAZINEActive
Quantity: 12.5 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT