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United States · US · US:55154-8104_913e2175-cc98-4f39-8941-1a46cc80b888

Multaq

Orange BookUNIISPLATC C01BD07

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

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeC01BD07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515481042
    1260 TABLET, FILM COATED in 1 BOTTLE (55154-8104-2)

Annotations

UNII (FDA Substance ID)
JQZ1L091Y2
DRONEDARONE
RxCUI 233698
Orange Book
N022425
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "JQZ1L091Y2",
    "rxcui": "233698",
    "inchikey": "ZQTNQVWKHCQYLQ-UHFFFAOYSA-N",
    "display_name": "DRONEDARONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3bd4006a-8bad-4909-ac6d-b6d84390155c": {
      "match": "brand_token",
      "title": "MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
      "spl_version": "13",
      "published_date": "2026-02-02"
    }
  },
  "productid": "55154-8104_913e2175-cc98-4f39-8941-1a46cc80b888",
  "productndc": "55154-8104",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022425",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 400MG BASE",
        "product_no": "001",
        "approval_date": "Jul 1, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DRONEDARONE",
  "proprietary_name": "Multaq",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022425",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dronedarone",
  "start_marketing_date": "20090701",
  "active_numerator_strength": "400"
}

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