MYQORZO

Orange BookUNIISPL

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

Identification

ManufacturerCytokinetics Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8211211530
30 TABLET, FILM COATED in 1 BOTTLE (82112-115-30)

Annotations

UNII (FDA Substance ID)

B1I77MH6K1

AFICAMTEN

Orange Book

N219083

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "B1I77MH6K1",
    "rxcui": null,
    "inchikey": "IOVAZWDIRCRMTM-OAHLLOKOSA-N",
    "display_name": "AFICAMTEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "fd778507-1274-4d1a-a659-5431d55c543a": {
      "match": "brand_token",
      "title": "MYQORZO (AFICAMTEN) TABLET, FILM COATED [CYTOKINETICS INC.]",
      "spl_version": "2",
      "published_date": "2026-01-12"
    }
  },
  "productid": "82112-115_f48908e6-f578-4e6c-b4ac-d4af4f01fdd6",
  "productndc": "82112-115",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "219083",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 19, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Dec 19, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Dec 19, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Dec 19, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AFICAMTEN",
  "proprietary_name": "MYQORZO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219083",
  "marketing_category": "NDA",
  "nonproprietary_name": "AFICAMTEN",
  "start_marketing_date": "20260112",
  "active_numerator_strength": "15"
}

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