CAMZYOS

Orange BookUNIISPLATC C01EB24

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

Identification

ManufacturerMyokardia, Inc.

CountryUS (United States)

ATC codeC01EB24

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7362511211
30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (73625-112-11)

Annotations

UNII (FDA Substance ID)

QX45B99R3J

MAVACAMTEN

RxCUI 2600867

Orange Book

N214998

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "QX45B99R3J",
    "rxcui": "2600867",
    "inchikey": "RLCLASQCAPXVLM-NSHDSACASA-N",
    "display_name": "MAVACAMTEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "669c936b-3ee6-4e36-8a22-79dd11b1255b": {
      "match": "brand_token",
      "title": "CAMZYOS (MAVACAMTEN) CAPSULE, GELATIN COATED [MYOKARDIA, INC.]",
      "spl_version": "8",
      "published_date": "2025-05-01"
    }
  },
  "productid": "73625-112_85338960-904b-44df-908f-b74b62902779",
  "productndc": "73625-112",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "214998",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Apr 28, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Apr 28, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Apr 28, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15MG",
        "product_no": "004",
        "approval_date": "Apr 28, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAVACAMTEN",
  "proprietary_name": "CAMZYOS",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214998",
  "marketing_category": "NDA",
  "nonproprietary_name": "mavacamten",
  "start_marketing_date": "20220428",
  "active_numerator_strength": "5"
}

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