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
2724117713
112 TABLET in 1 BOTTLE (27241-177-13)

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": "27241-177_6a48a21b-0533-4939-b7c8-8b7723149e85",
  "productndc": "27241-177",
  "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": "25"
}

Related drugs

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