TETRABENAZINE

Product NDC
51224-426
11-digit product format
512240426
Labeler code
51224
Product ID
51224-426_5c40b7db-7ab7-4580-af2f-e1b36a82e2c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TETRABENAZINE
Dosage form
TABLET
Route
ORAL
Labeler
TAGI Pharma, Inc.
Application
ANDA207682
Marketing category
ANDA
Marketing start
2017-02-01
Marketing end
0000-00-00
Substance
TETRABENAZINE
Active strength
25 mg/1
Pharmacologic classes
Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-426-10EA - Each51224-42663b7e180-a89b-410b-a9f8-ab3edac7c39012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-426TETRABENAZINE TABLET [TAGI PHARMA, INC.]5Legacy NDC20231026_b041d7a5-a678-4f80-8d78-a42d3d003fbc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51224-426-1051224042610112 TABLET in 1 BOTTLE (51224-426-10) 112 tablet2017-02-010000-00-00NoNoCurrent