AUSTEDO XR

Orange BookSPL

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

Identification

ManufacturerTeva Neuroscience, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6854647728
1 KIT in 1 BLISTER PACK (68546-477-28) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07)
ndc11
6854647729
1 BLISTER PACK in 1 CARTON (68546-477-29) / 1 KIT in 1 BLISTER PACK * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07)

Annotations

Orange Book

N216354

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "68546-477_69071a25-792d-4eec-a12a-1bb30c8fc881",
  "productndc": "68546-477",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "AUSTEDO XR",
  "active_ingred_unit": null,
  "application_number": "NDA216354",
  "marketing_category": "NDA",
  "nonproprietary_name": "deutetrabenazine",
  "start_marketing_date": "20240701",
  "active_numerator_strength": null
}

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