Xenazine

Orange BookUNIIATC N07XX06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerLundbeck Pharmaceuticals LLC

CountryUS (United States)

ATC codeN07XX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6738642201
112 TABLET in 1 BOTTLE (67386-422-01)

Annotations

UNII (FDA Substance ID)

Z9O08YRN8O

TETRABENAZINE

RxCUI 10390

Orange Book

N021894

ABAB

Raw payload (JSON)

{
  "unii": {
    "unii": "Z9O08YRN8O",
    "rxcui": "10390",
    "inchikey": "MKJIEFSOBYUXJB-HOCLYGCPSA-N;MKJIEFSOBYUXJB-GDBMZVCRSA-N",
    "display_name": "TETRABENAZINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "67386-422_6f524695-2fc1-4c54-9212-69cff22cdfa7",
  "productndc": "67386-422",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021894",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Aug 15, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Aug 15, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETRABENAZINE",
  "proprietary_name": "Xenazine",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021894",
  "marketing_category": "NDA",
  "nonproprietary_name": "tetrabenazine",
  "start_marketing_date": "20081124",
  "active_numerator_strength": "25"
}

Related drugs

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