niraparib tosylate monohydrate and abiraterone acetate

NDC product · U.S. Food and Drug Administration (openFDA) · United States

Product NDC 47049-059
Package NDC 47049-059-00
SPL ID 5afabbea-2fc4-8c4f-e063-6394a90a80de

What the source publishes

Labeler: Patheon France S.A.S.
Active ingredients: niraparib tosylate monohydrate and abiraterone acetate
Form: TABLET, FILM COATED
Administrative status: present-in-source-snapshot
Marketing status: DRUG FOR FURTHER PROCESSING
Product type: DRUG FOR FURTHER PROCESSING

Names this record is found by

Complete source data

us:fda:ndc:47049-059_5afabbea-2fc4-8c4f-e063-6394a90a80de

{
  "name": "niraparib tosylate monohydrate and abiraterone acetate",
  "splId": "5afabbea-2fc4-8c4f-e063-6394a90a80de",
  "labels": [],
  "routes": [],
  "labeler": "Patheon France S.A.S.",
  "finished": false,
  "packaging": [
    {
      "description": "6500 TABLET, FILM COATED in 1 DRUM (47049-059-00)",
      "package_ndc": "47049-059-00",
      "identifierStatus": "well-formed",
      "marketing_start_date": "01-JAN-26"
    }
  ],
  "productId": "47049-059_5afabbea-2fc4-8c4f-e063-6394a90a80de",
  "useDomain": "unknown",
  "dosageForm": "TABLET, FILM COATED",
  "productNdc": "47049-059",
  "deaSchedule": null,
  "genericName": "niraparib tosylate monohydrate and abiraterone acetate",
  "productType": "DRUG FOR FURTHER PROCESSING",
  "listingStatus": "present-in-source-snapshot",
  "targetSpecies": [],
  "approvalStatus": "not-established-by-ndc-listing",
  "labelAssociation": "openFDA-harmonized-set-ids; not a product-level approval match",
  "marketingEndDate": null,
  "activeIngredients": [
    {
      "name": "NIRAPARIB TOSYLATE MONOHYDRATE",
      "strength": "50 mg/1"
    },
    {
      "name": "ABIRATERONE ACETATE",
      "strength": "500 mg/1"
    }
  ],
  "applicationNumber": null,
  "marketingCategory": "DRUG FOR FURTHER PROCESSING",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20260101",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "unknown",
  "harmonizedIdentifiers": {},
  "listingExpirationDate": "20271231"
}

NDC Directory

U.S. Food and Drug Administration / openFDA

Retrieved: November 15, 2026
Licence: CC0 1.0
Source id: us.fda.ndc

Official source

What this source does not establish

Complete published endpoint, not a claim that FDA lists every medicine used in the US.
NDC listing, marketing category and application-number assertions are not proof of approval.
Tentative approval, discontinued products and historical submissions remain distinct.
Official document links only; linked documents have not been relicensed or mirrored.
No state restrictions, individual eligibility, or prescribing recommendations inferred.
UNII and RxNorm identifiers are source-asserted openFDA harmonization at record scope; arrays do not pair identifiers to individual products or ingredients, and are not GSID/PhPID or substitution evidence.

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