Tetrabenazine

Orange BookUNIISPLATC N07XX06

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN07XX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2315593963
112 TABLET in 1 BOTTLE (23155-939-63)

Annotations

UNII (FDA Substance ID)

Z9O08YRN8O

TETRABENAZINE

RxCUI 10390

Orange Book

A213316

ABAB

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": "23155-939_7b438263-54f4-4cb4-b1af-a84276c751de",
  "productndc": "23155-939",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213316",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Jan 22, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jan 22, 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": "ANDA213316",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tetrabenazine",
  "start_marketing_date": "20250901",
  "active_numerator_strength": "25"
}

Related drugs

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