Tetrabenazine

Orange BookUNIISPLATC N07XX06

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

Identification

ManufacturerAjanta Pharma USA Inc.

CountryUS (United States)

ATC codeN07XX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2724117613
112 TABLET in 1 BOTTLE (27241-176-13)

Annotations

UNII (FDA Substance ID)

Z9O08YRN8O

TETRABENAZINE

RxCUI 10390

Orange Book

A213621

DailyMed SPL labels

1 version tracked

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",
  "spl_meta": {
    "5867189c-17bd-4e70-a079-c4730f9950d1": {
      "match": "brand_token",
      "title": "TETRABENAZINE TABLET [OCEANSIDE PHARMACEUTICALS]",
      "spl_version": "9",
      "published_date": "2026-04-09"
    }
  },
  "productid": "27241-176_6a48a21b-0533-4939-b7c8-8b7723149e85",
  "productndc": "27241-176",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213621",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Dec 4, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Dec 4, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETRABENAZINE",
  "proprietary_name": "Tetrabenazine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213621",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tetrabenazine",
  "start_marketing_date": "20201227",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code N07XX06.

Access this data programmatically

Query Tetrabenazine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs