Tetrabenazine

Product NDC
23155-939
11-digit product format
231550939
Labeler code
23155
Product ID
23155-939_7b438263-54f4-4cb4-b1af-a84276c751de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetrabenazine
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA213316
Marketing category
ANDA
Marketing start
2025-09-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tetrabenazine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRABENAZINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ9O08YRN8O
Rxcui199592, 805464

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dd868135-b25c-abb7-9326-3e7691e6893fProduct name820200611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-939-63Tetrabenazine112 in 1 BOTTLETABLET1121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-939-63EA - Each23155-93950d3ace9-453d-45cf-8230-88631d56d51b12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
805464tetrabenazine 12.5 MG Oral TabletPSN5042f30c-c922-4835-bf6d-40905f2dc76c1
199592tetrabenazine 25 MG Oral TabletPSN5042f30c-c922-4835-bf6d-40905f2dc76c1
805464tetrabenazine 12.5 MG Oral TabletSCD5042f30c-c922-4835-bf6d-40905f2dc76c1
199592tetrabenazine 25 MG Oral TabletSCD5042f30c-c922-4835-bf6d-40905f2dc76c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-939-6323155093963112 TABLET in 1 BOTTLE (23155-939-63) 112 tablet2025-09-01NoNoCurrent