Dapagliflozin

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

  • Product NDC 76397-059
  • Package NDC 76397-059-01
  • Package NDC 76397-059-02
  • Package NDC 76397-059-04
  • Package NDC 76397-059-05
  • SPL ID 581aba03-492e-8a4c-e063-6394a90aed5e

What the source publishes

Labeler
Zhejiang Ausun Pharmaceutical Co., Ltd.
Active ingredients
Dapagliflozin
Form
POWDER
Administrative status
present-in-source-snapshot
Marketing status
BULK INGREDIENT
Product type
BULK INGREDIENT

Names this record is found by

Complete source data
us:fda:ndc:76397-059_581aba03-492e-8a4c-e063-6394a90aed5e
{
  "name": "Dapagliflozin",
  "splId": "581aba03-492e-8a4c-e063-6394a90aed5e",
  "labels": [],
  "routes": [],
  "labeler": "Zhejiang Ausun Pharmaceutical Co., Ltd.",
  "finished": false,
  "packaging": [
    {
      "description": "1 kg in 1 DRUM (76397-059-01)",
      "package_ndc": "76397-059-01",
      "identifierStatus": "well-formed",
      "marketing_start_date": "27-JUL-26"
    },
    {
      "description": "25 kg in 1 DRUM (76397-059-02)",
      "package_ndc": "76397-059-02",
      "identifierStatus": "well-formed",
      "marketing_start_date": "27-JUL-26"
    },
    {
      "description": "5 kg in 1 DRUM (76397-059-04)",
      "package_ndc": "76397-059-04",
      "identifierStatus": "well-formed",
      "marketing_start_date": "27-JUL-26"
    },
    {
      "description": "10 kg in 1 DRUM (76397-059-05)",
      "package_ndc": "76397-059-05",
      "identifierStatus": "well-formed",
      "marketing_start_date": "27-JUL-26"
    }
  ],
  "productId": "76397-059_581aba03-492e-8a4c-e063-6394a90aed5e",
  "useDomain": "unknown",
  "dosageForm": "POWDER",
  "productNdc": "76397-059",
  "deaSchedule": null,
  "genericName": "Dapagliflozin",
  "productType": "BULK INGREDIENT",
  "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": "DAPAGLIFLOZIN",
      "strength": "1 kg/kg"
    }
  ],
  "applicationNumber": null,
  "marketingCategory": "BULK INGREDIENT",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20260727",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "unknown",
  "harmonizedIdentifiers": {},
  "listingExpirationDate": "20271231"
}

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