AUSTEDO XR

Orange BookUNIISPLATC N07XX16

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

Identification

ManufacturerTeva Neuroscience, Inc.

CountryUS (United States)

ATC codeN07XX16

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6854647056
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-470-56)

Annotations

UNII (FDA Substance ID)

P341G6W9NB

DEUTETRABENAZINE

RxCUI 1876905

Orange Book

N216354

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "P341G6W9NB",
    "rxcui": "1876905",
    "inchikey": "MKJIEFSOBYUXJB-WEZHFFAMSA-N;MKJIEFSOBYUXJB-VFJJUKLQSA-N",
    "display_name": "DEUTETRABENAZINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7ea3c60a-45c7-44cc-afc2-d87fa53993c0": {
      "match": "brand_token",
      "title": "AUSTEDO (DEUTETRABENAZINE) TABLET, COATED AUSTEDO (DEUTETRABENAZINE) KIT AUSTEDO XR (DEUTETRABENAZINE) TABLET, FILM COATED, EXTENDED RELEASE [TEVA NEUROSCIENCE, INC.]",
      "spl_version": "35",
      "published_date": "2025-03-24"
    }
  },
  "productid": "68546-470_69071a25-792d-4eec-a12a-1bb30c8fc881",
  "productndc": "68546-470",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "216354",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "6MG",
        "product_no": "001",
        "approval_date": "Feb 17, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "12MG",
        "product_no": "002",
        "approval_date": "Feb 17, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "24MG",
        "product_no": "003",
        "approval_date": "Feb 17, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "May 29, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "36MG",
        "product_no": "005",
        "approval_date": "May 29, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "42MG",
        "product_no": "006",
        "approval_date": "May 29, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "48MG",
        "product_no": "007",
        "approval_date": "May 29, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "18MG",
        "product_no": "008",
        "approval_date": "Jul 1, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEUTETRABENAZINE",
  "proprietary_name": "AUSTEDO XR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216354",
  "marketing_category": "NDA",
  "nonproprietary_name": "deutetrabenazine",
  "start_marketing_date": "20230221",
  "active_numerator_strength": "6"
}

Related drugs

Other records sharing ATC code N07XX16.

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