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
b7d93006-7f06-4da4-985e-6b948c2468e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2023
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code47335-179
Application NumberANDA206129
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 10, 2023
Generic NameTetrabenazine
INGREDIENTS (8)
TETRABENAZINEActive
Quantity: 25 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Tetrabenazine
PRODUCT DETAILS
NDC Product Code47335-277
Application NumberANDA206129
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 10, 2023
Generic NameTetrabenazine
INGREDIENTS (7)
TETRABENAZINEActive
Quantity: 12.5 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Drug Labeling Information
Boxed Warning Section
LOINC: 34066-1Updated: 9/1/2023
WARNING: DEPRESSION AND SUICIDALITY****
See full prescribing information for complete boxed warning.