Tetrabenazine
TETRABENAZINE tablets. 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
cbfb791e-26ac-9fb5-e053-2995a90ac7e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
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 Code51407-480
Application NumberANDA206093
Product Classification
M
Marketing Category
C73584
G
Generic Name
tetrabenazine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TETRABENAZINEActive
Quantity: 12.5 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
tetrabenazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-481
Application NumberANDA206093
Product Classification
M
Marketing Category
C73584
G
Generic Name
tetrabenazine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2023
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TETRABENAZINEActive
Quantity: 25 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB