tetrabenazine

Generic: tetrabenazine

Labeler: precision dose inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tetrabenazine
Generic Name tetrabenazine
Labeler precision dose inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tetrabenazine 12.5 mg/1

Manufacturer
Precision Dose Inc.

Identifiers & Regulatory

Product NDC 68094-905
Product ID 68094-905_aca55884-1eb4-4a76-8c7f-96c782849337
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207682
Listing Expiration 2026-12-31
Marketing Start 2023-12-01

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 68094905
Hyphenated Format 68094-905

Supplemental Identifiers

RxCUI
199592 805464
UPC
0368094805100 0368094905107
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 ANDA207682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 112 TABLET in 1 BOTTLE, PLASTIC (68094-905-10)
source: ndc

Packages (1)

68094-905-10 112 TABLET in 1 BOTTLE, PLASTIC (68094-905-10)

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": "aca55884-1eb4-4a76-8c7f-96c782849337", "openfda": {"nui": ["N0000190856", "N0000190855"], "upc": ["0368094805100", "0368094905107"], "unii": ["Z9O08YRN8O"], "rxcui": ["199592", "805464"], "spl_set_id": ["aca55884-1eb4-4a76-8c7f-96c782849337"], "pharm_class_epc": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Precision Dose Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "112 TABLET in 1 BOTTLE, PLASTIC (68094-905-10)", "package_ndc": "68094-905-10", "marketing_start_date": "20231201"}], "brand_name": "Tetrabenazine", "product_id": "68094-905_aca55884-1eb4-4a76-8c7f-96c782849337", "dosage_form": "TABLET", "pharm_class": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]", "Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "product_ndc": "68094-905", "generic_name": "TETRABENAZINE", "labeler_name": "Precision Dose Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tetrabenazine", "active_ingredients": [{"name": "TETRABENAZINE", "strength": "12.5 mg/1"}], "application_number": "ANDA207682", "marketing_category": "ANDA", "marketing_start_date": "20231201", "listing_expiration_date": "20261231"}