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United States · US · US:63020-198_176eb255-05c0-4cfc-874f-1fb57136d34d

Alunbrig

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6302019830
    1 KIT in 1 CARTON (63020-198-30) * 7 TABLET, FILM COATED in 1 BOTTLE (63020-090-07) * 23 TABLET, FILM COATED in 1 BOTTLE (63020-180-23)

Annotations

Orange Book
N208772
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "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": "63020-198_176eb255-05c0-4cfc-874f-1fb57136d34d",
  "productndc": "63020-198",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "Alunbrig",
  "active_ingred_unit": null,
  "application_number": "NDA208772",
  "marketing_category": "NDA",
  "nonproprietary_name": "brigatinib",
  "start_marketing_date": "20170428",
  "active_numerator_strength": null
}

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