tetrabenazine

Generic: tetrabenazine

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tetrabenazine
Generic Name tetrabenazine
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tetrabenazine 12.5 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-938
Product ID 23155-938_7b438263-54f4-4cb4-b1af-a84276c751de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213316
Listing Expiration 2026-12-31
Marketing Start 2025-09-01

Pharmacologic Class

Established (EPC)
vesicular monoamine transporter 2 inhibitor [epc]
Mechanism of Action
vesicular monoamine transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155938
Hyphenated Format 23155-938

Supplemental Identifiers

RxCUI
199592 805464
UPC
0323155939637 0323155938630
UNII
Z9O08YRN8O
NUI
N0000190856 N0000190855

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tetrabenazine (source: ndc)
Generic Name tetrabenazine (source: ndc)
Application Number ANDA213316 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 112 TABLET in 1 BOTTLE (23155-938-63)
source: ndc

Packages (1)

23155-938-63 112 TABLET in 1 BOTTLE (23155-938-63)

Ingredients (1)

tetrabenazine (12.5 mg/1)

Linked Drug Pages (1)

Tetrabenazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7b438263-54f4-4cb4-b1af-a84276c751de", "openfda": {"nui": ["N0000190856", "N0000190855"], "upc": ["0323155939637", "0323155938630"], "unii": ["Z9O08YRN8O"], "rxcui": ["199592", "805464"], "spl_set_id": ["5042f30c-c922-4835-bf6d-40905f2dc76c"], "pharm_class_epc": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "112 TABLET in 1 BOTTLE (23155-938-63)", "package_ndc": "23155-938-63", "marketing_start_date": "20250901"}], "brand_name": "Tetrabenazine", "product_id": "23155-938_7b438263-54f4-4cb4-b1af-a84276c751de", "dosage_form": "TABLET", "pharm_class": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]", "Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "product_ndc": "23155-938", "generic_name": "Tetrabenazine", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tetrabenazine", "active_ingredients": [{"name": "TETRABENAZINE", "strength": "12.5 mg/1"}], "application_number": "ANDA213316", "marketing_category": "ANDA", "marketing_start_date": "20250901", "listing_expiration_date": "20261231"}