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
49587379-1cc0-48ff-9f2f-517079cf499d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 2020
Manufacturers
FDA
Slate Run Pharmaceuticals, LLC
DUNS: 039452765
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 Code70436-101
Application NumberANDA213316
Product Classification
M
Marketing Category
C73584
G
Generic Name
tetrabenazine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 22, 2020
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TETRABENAZINEActive
Quantity: 12.5 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
tetrabenazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-102
Application NumberANDA213316
Product Classification
M
Marketing Category
C73584
G
Generic Name
tetrabenazine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 22, 2020
FDA Product Classification
INGREDIENTS (6)
TETRABENAZINEActive
Quantity: 25 mg in 1 1
Code: Z9O08YRN8O
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT