Pomalidomide

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

  • Product NDC 70095-059
  • Package NDC 70095-059-01
  • Package NDC 70095-059-02
  • Application number ANDA210232
  • SPL ID 5a6cdeaf-06a4-d9db-e063-6294a90a906e
  • SPL set ID 3c222961-5398-4185-b2d0-defe90230094
  • UNII D2UX06XLB5
  • RxCUI 1369718
  • RxCUI 1369726
  • RxCUI 1369730
  • RxCUI 1369734

What the source publishes

Labeler
Sun Pharmaceutical Industries, Inc.
Active ingredients
Pomalidomide
Form
CAPSULE
Routes
ORAL
Administrative status
present-in-source-snapshot
Marketing status
ANDA
Product type
HUMAN PRESCRIPTION DRUG
Prescription
Prescription or restricted

Names this record is found by

Complete source data
us:fda:ndc:70095-059_5a6cdeaf-06a4-d9db-e063-6294a90a906e
{
  "name": "Pomalidomide",
  "splId": "5a6cdeaf-06a4-d9db-e063-6294a90a906e",
  "labels": [
    {
      "setId": "3c222961-5398-4185-b2d0-defe90230094",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c222961-5398-4185-b2d0-defe90230094",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=3c222961-5398-4185-b2d0-defe90230094"
    }
  ],
  "routes": [
    "ORAL"
  ],
  "labeler": "Sun Pharmaceutical Industries, Inc.",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "21 CAPSULE in 1 BOTTLE (70095-059-01)",
      "package_ndc": "70095-059-01",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20260831"
    },
    {
      "sample": false,
      "description": "100 CAPSULE in 1 BOTTLE (70095-059-02)",
      "package_ndc": "70095-059-02",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20260831"
    }
  ],
  "productId": "70095-059_5a6cdeaf-06a4-d9db-e063-6294a90a906e",
  "useDomain": "unknown",
  "dosageForm": "CAPSULE",
  "productNdc": "70095-059",
  "deaSchedule": null,
  "genericName": "Pomalidomide",
  "productType": "HUMAN PRESCRIPTION DRUG",
  "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": "POMALIDOMIDE",
      "strength": "3 mg/1"
    }
  ],
  "applicationNumber": "ANDA210232",
  "marketingCategory": "ANDA",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20260831",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "prescription-or-restricted",
  "harmonizedIdentifiers": {
    "nui": [
      "N0000184014"
    ],
    "unii": [
      "D2UX06XLB5"
    ],
    "rxcui": [
      "1369718",
      "1369726",
      "1369730",
      "1369734"
    ],
    "spl_set_id": [
      "3c222961-5398-4185-b2d0-defe90230094"
    ],
    "pharm_class_epc": [
      "Thalidomide Analog [EPC]"
    ],
    "manufacturer_name": [
      "Sun Pharmaceutical Industries, Inc."
    ],
    "is_original_packager": [
      true
    ]
  },
  "listingExpirationDate": "20271231"
}

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