xenazine

Generic: tetrabenazine

Labeler: lundbeck pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xenazine
Generic Name tetrabenazine
Labeler lundbeck pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tetrabenazine 25 mg/1

Manufacturer
Lundbeck Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 67386-422
Product ID 67386-422_6f524695-2fc1-4c54-9212-69cff22cdfa7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021894
Listing Expiration 2026-12-31
Marketing Start 2008-11-24

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 67386422
Hyphenated Format 67386-422

Supplemental Identifiers

RxCUI
199592 805462 805464 805466
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 xenazine (source: ndc)
Generic Name tetrabenazine (source: ndc)
Application Number NDA021894 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 112 TABLET in 1 BOTTLE (67386-422-01)
source: ndc

Packages (1)

67386-422-01 112 TABLET in 1 BOTTLE (67386-422-01)

Ingredients (1)

tetrabenazine (25 mg/1)

Linked Drug Pages (1)

Xenazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6f524695-2fc1-4c54-9212-69cff22cdfa7", "openfda": {"nui": ["N0000190856", "N0000190855"], "unii": ["Z9O08YRN8O"], "rxcui": ["199592", "805462", "805464", "805466"], "spl_set_id": ["ac768bab-8afa-4446-bc7f-caeeffec0cda"], "pharm_class_epc": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Lundbeck Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "112 TABLET in 1 BOTTLE (67386-422-01)", "package_ndc": "67386-422-01", "marketing_start_date": "20081124"}], "brand_name": "Xenazine", "product_id": "67386-422_6f524695-2fc1-4c54-9212-69cff22cdfa7", "dosage_form": "TABLET", "pharm_class": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]", "Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "product_ndc": "67386-422", "generic_name": "tetrabenazine", "labeler_name": "Lundbeck Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xenazine", "active_ingredients": [{"name": "TETRABENAZINE", "strength": "25 mg/1"}], "application_number": "NDA021894", "marketing_category": "NDA", "marketing_start_date": "20081124", "listing_expiration_date": "20261231"}