tetrabenazine

Generic: tetrabenazine

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tetrabenazine
Generic Name tetrabenazine
Labeler apotex corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tetrabenazine 25 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3883
Product ID 60505-3883_e5459b2b-579f-6e7f-91a9-23ee61f86399
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206093
Listing Expiration 2026-12-31
Marketing Start 2020-06-18

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 605053883
Hyphenated Format 60505-3883

Supplemental Identifiers

RxCUI
199592 805464
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 ANDA206093 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 112 TABLET in 1 BOTTLE (60505-3883-7)
source: ndc

Packages (1)

60505-3883-7 112 TABLET in 1 BOTTLE (60505-3883-7)

Ingredients (1)

tetrabenazine (25 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": "e5459b2b-579f-6e7f-91a9-23ee61f86399", "openfda": {"nui": ["N0000190856", "N0000190855"], "unii": ["Z9O08YRN8O"], "rxcui": ["199592", "805464"], "spl_set_id": ["471ac1d8-e3ad-7729-87c5-c26ae92c32eb"], "pharm_class_epc": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "112 TABLET in 1 BOTTLE (60505-3883-7)", "package_ndc": "60505-3883-7", "marketing_start_date": "20200618"}], "brand_name": "Tetrabenazine", "product_id": "60505-3883_e5459b2b-579f-6e7f-91a9-23ee61f86399", "dosage_form": "TABLET", "pharm_class": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]", "Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "product_ndc": "60505-3883", "generic_name": "tetrabenazine", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tetrabenazine", "active_ingredients": [{"name": "TETRABENAZINE", "strength": "25 mg/1"}], "application_number": "ANDA206093", "marketing_category": "ANDA", "marketing_start_date": "20200618", "listing_expiration_date": "20261231"}