Alunbrig

Orange BookUNIISPLATC L01ED04

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

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.

CountryUS (United States)

ATC codeL01ED04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6302018030
30 TABLET, FILM COATED in 1 BOTTLE (63020-180-30)

Annotations

UNII (FDA Substance ID)

HYW8DB273J

BRIGATINIB

RxCUI 1921217

Orange Book

N208772

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "HYW8DB273J",
    "rxcui": "1921217",
    "inchikey": "AILRADAXUVEEIR-UHFFFAOYSA-N",
    "display_name": "BRIGATINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0fe9ff20-d402-41f3-bc1e-7002ea7007db": {
      "match": "brand_token",
      "title": "ALUNBRIG (BRIGATINIB) TABLET, FILM COATED ALUNBRIG (BRIGATINIB) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "17",
      "published_date": "2026-01-19"
    }
  },
  "productid": "63020-180_176eb255-05c0-4cfc-874f-1fb57136d34d",
  "productndc": "63020-180",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208772",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Apr 28, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "90MG",
        "product_no": "002",
        "approval_date": "Apr 28, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "180MG",
        "product_no": "003",
        "approval_date": "Oct 2, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIGATINIB",
  "proprietary_name": "Alunbrig",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208772",
  "marketing_category": "NDA",
  "nonproprietary_name": "brigatinib",
  "start_marketing_date": "20170428",
  "active_numerator_strength": "180"
}

Related drugs

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