LUMAKRAS

Orange BookUNIISPLATC L01XX73

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

Identification

ManufacturerAmgen Inc

CountryUS (United States)

ATC codeL01XX73

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5551350450
1 BOTTLE, PLASTIC in 1 CARTON (55513-504-50) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

2B2VM6UC8G

SOTORASIB

RxCUI 2550714

Orange Book

N214665

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2B2VM6UC8G",
    "rxcui": "2550714",
    "inchikey": "NXQKSXLFSAEQCZ-SFHVURJKSA-N",
    "display_name": "SOTORASIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c80a362c-7ac3-4894-a076-0691e68ef8c1": {
      "match": "brand_token",
      "title": "LUMAKRAS (SOTORASIB) TABLET, COATED [AMGEN INC]",
      "spl_version": "19",
      "published_date": "2025-01-30"
    }
  },
  "productid": "55513-504_8f611e67-8c58-4413-8b81-a200fa7f30e8",
  "productndc": "55513-504",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "214665",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "May 28, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "320MG",
        "product_no": "002",
        "approval_date": "Jan 20, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "240MG",
        "product_no": "003",
        "approval_date": "Jun 26, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SOTORASIB",
  "proprietary_name": "LUMAKRAS",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214665",
  "marketing_category": "NDA",
  "nonproprietary_name": "sotorasib",
  "start_marketing_date": "20230202",
  "active_numerator_strength": "320"
}

Related drugs

Other records sharing ATC code L01XX73.

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