{
  "release_id": "c7fb95f1d15a7d13",
  "id": "maternal:cervidil",
  "owner": "maternal",
  "kind": "product",
  "slug": "cervidil",
  "name": "Cervidil (dinoprostone vaginal insert)",
  "aliases": [
    "Cervidil"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "Cervidil is a dinoprostone vaginal insert with a US label from Ferring Pharmaceuticals, approved in the United States under application NDA020411. Its US label says it is for starting or continuing cervical ripening in pregnant women at or near term who have a medical or obstetrical reason for labour to be induced.",
  "summary_technical": "US approved prostaglandin for cervical ripening before induction. openFDA label set id f3bc9031-0620-4a50-b440-f661cadfeb1d, version 10, effective 2023-06-02, manufacturer Ferring Pharmaceuticals Inc., route vaginal; dosage form extended-release insert, 10 mg dinoprostone per the Drugs@FDA record. Only the US label was read. The label wording is the dataset's copy as of the date fetched.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [],
  "navigation": {
    "maternal": {
      "life-stage": [
        "childbirth"
      ],
      "care-area": [
        "labour-and-birth"
      ]
    }
  },
  "payload": {
    "subtype": "medicine",
    "model_or_formulation": "Dinoprostone 10 mg extended-release vaginal insert",
    "version": "openFDA label version 10, effective 2023-06-02",
    "intended_use_snapshots": [
      "maternal:openfda-label-f3bc9031-0620-4a50-b440-f661cadfeb1d-2026-10-14"
    ]
  },
  "content_digest": "343e910521e13a012d321901b8c7dbbca60c2551f9a63bd82c21ff49c019b26d",
  "review": {
    "content_digest": "343e910521e13a012d321901b8c7dbbca60c2551f9a63bd82c21ff49c019b26d",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [
    {
      "release_id": "c7fb95f1d15a7d13",
      "id": "maternal:claim-fda-nda020411-cervidil",
      "owner": "maternal",
      "subject_entity_id": "maternal:cervidil",
      "category": "regulatory",
      "statement": "FDA lists an original approval of NDA020411 for Cervidil (dinoprostone vaginal insert) on 1995-03-30, classified Type 3, new dosage form; the sponsor in Drugs@FDA is Ferring Pharmaceuticals. The US label (version 10, effective 2023-06-02) says Cervidil is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.",
      "context": {
        "id": "maternal:ctx-fda-nda020411-us",
        "label": "Pregnant women at or near term with a medical or obstetrical indication for induction of labour, US label for Cervidil (NDA020411)",
        "recipient": "maternal",
        "population": "Pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labour, for initiation or continuation of cervical ripening.",
        "care_setting": "Not stated in the source",
        "geography": "United States (FDA-approved labelling)",
        "life_stage_note": "Pregnancy at or near term",
        "life_stage_terms": null,
        "gestational_age_min_days": null,
        "gestational_age_max_days": null,
        "gestational_age_basis": null,
        "postnatal_age_min_days": null,
        "postnatal_age_max_days": null,
        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory context)",
        "eligibility": {
          "inclusion": [
            "Pregnant women at or near term with a medical or obstetrical indication for induction of labour"
          ],
          "exclusion": []
        }
      },
      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "The date is the original submission's action date in Drugs@FDA, not the date of the current label. The indication wording is from the openFDA copy of the label and was not compared with the DailyMed page. Approval is not a recommendation for any woman, and labelled uses differ by country.",
      "editorial_state": "draft",
      "checked_at": "2026-10-14",
      "next_review_due": null,
      "valid_from": null,
      "valid_to": null,
      "citations": [
        {
          "evidence_role": "supports",
          "locator": "results[0].submissions: original submission (ORIG 1) with status AP",
          "applicability_note": "openFDA drugsfda JSON, CC0.",
          "snapshot": {
            "id": "maternal:openfda-drugsfda-nda020411-2026-10-14",
            "retrieved_at": "2026-10-14T18:23:44Z",
            "content_hash": "efe6b77bfc1afed8718173a9d1f6ccbcab641d9cfde40ac97f52e9676bc1c05a",
            "source_effective_date": "2026-10-13",
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:fda-nda020411",
            "source_type": "regulator",
            "title": "FDA new drug application NDA020411, CERVIDIL: openFDA Drugs@FDA record and Drugs@FDA approval history page",
            "canonical_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020411",
            "identifiers": [
              {
                "scheme": "fda-nda",
                "value": "NDA020411",
                "normalized_value": "NDA020411",
                "match": "exact",
                "version": null,
                "label": null,
                "from_source": false
              }
            ],
            "publication_date": null,
            "publisher": "U.S. Food and Drug Administration",
            "edition": "Two retrievals on 2026-10-14. The openFDA drugsfda JSON record (meta.last_updated 2026-10-13) gives the application number, sponsor, products, active ingredient, identifiers and the submission history with status dates written YYYYMMDD. The Drugs@FDA overview page for the application gives the original approval date with the date written MM/DD/YYYY.",
            "reuse_basis": "openFDA data is public domain under CC0 (https://open.fda.gov/license/, fetched as mg-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The FDA website policies page (fetched as mg-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says FDA website content is not copyrighted unless otherwise noted. The openFDA JSON is committed at research/snapshots/mg-openfda-drugsfda-NDA020411.json and the Drugs@FDA page at research/snapshots/mg-fda-daf-020411.html.",
            "public_text": "quote"
          }
        },
        {
          "evidence_role": "supports",
          "locator": "Original Approvals or Tentative Approvals: action date, submission and classification",
          "applicability_note": "Drugs@FDA overview page; FDA website content is not copyrighted.",
          "snapshot": {
            "id": "maternal:fda-daf-020411-2026-10-14",
            "retrieved_at": "2026-10-14T18:30:46Z",
            "content_hash": "cc140ad1727ce0984270a9a51fe839f559a2c276f8a795d280c0151970eba772",
            "source_effective_date": null,
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:fda-nda020411",
            "source_type": "regulator",
            "title": "FDA new drug application NDA020411, CERVIDIL: openFDA Drugs@FDA record and Drugs@FDA approval history page",
            "canonical_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020411",
            "identifiers": [
              {
                "scheme": "fda-nda",
                "value": "NDA020411",
                "normalized_value": "NDA020411",
                "match": "exact",
                "version": null,
                "label": null,
                "from_source": false
              }
            ],
            "publication_date": null,
            "publisher": "U.S. Food and Drug Administration",
            "edition": "Two retrievals on 2026-10-14. The openFDA drugsfda JSON record (meta.last_updated 2026-10-13) gives the application number, sponsor, products, active ingredient, identifiers and the submission history with status dates written YYYYMMDD. The Drugs@FDA overview page for the application gives the original approval date with the date written MM/DD/YYYY.",
            "reuse_basis": "openFDA data is public domain under CC0 (https://open.fda.gov/license/, fetched as mg-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The FDA website policies page (fetched as mg-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says FDA website content is not copyrighted unless otherwise noted. The openFDA JSON is committed at research/snapshots/mg-openfda-drugsfda-NDA020411.json and the Drugs@FDA page at research/snapshots/mg-fda-daf-020411.html.",
            "public_text": "quote"
          }
        },
        {
          "evidence_role": "supports",
          "locator": "results[0].indications_and_usage",
          "applicability_note": "openFDA label record, CC0; label version 10.",
          "snapshot": {
            "id": "maternal:openfda-label-f3bc9031-0620-4a50-b440-f661cadfeb1d-2026-10-14",
            "retrieved_at": "2026-10-14T18:24:06Z",
            "content_hash": "0f4a41c3fc1716760af22915d3dd8267b30998f3a297aa051e7da9421e05a9a9",
            "source_effective_date": "2023-06-02",
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:openfda-label-f3bc9031-0620-4a50-b440-f661cadfeb1d",
            "source_type": "label",
            "title": "CERVIDIL drug label (openFDA record, set id f3bc9031-0620-4a50-b440-f661cadfeb1d)",
            "canonical_url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f3bc9031-0620-4a50-b440-f661cadfeb1d",
            "identifiers": [
              {
                "scheme": "spl-set-id",
                "value": "f3bc9031-0620-4a50-b440-f661cadfeb1d",
                "normalized_value": "f3bc9031-0620-4a50-b440-f661cadfeb1d",
                "match": "exact",
                "version": null,
                "label": null,
                "from_source": false
              }
            ],
            "publication_date": null,
            "publisher": "U.S. Food and Drug Administration (openFDA drug label endpoint)",
            "edition": "openFDA drug label record, label effective 20230602, dataset last updated 2026-10-13. The openFDA record is the label as of the dataset date; it is not the current label on DailyMed.",
            "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The label text is the manufacturer's labeling as FDA publishes it; check the openFDA documentation for a not-in-the-public-domain warning before quoting beyond short passages. The raw file is committed at research/snapshots/mg-openfda-label-f3bc9031-0620-4a50-b440-f661cadfeb1d.json.",
            "public_text": "quote"
          }
        }
      ],
      "review": {
        "content_digest": "073c0fb4756ef50e792cdf6b2079bee9fffcda1d78879acaf070fe96f43eff10",
        "current": [],
        "conflicting": [],
        "stale": [],
        "inactive": []
      },
      "api_path": "api/v1/claims/maternal--claim-fda-nda020411-cervidil.json"
    }
  ],
  "decisions": [
    {
      "type": "regulatory_decision",
      "id": "maternal:regdec-fda-nda020411",
      "product_id": "maternal:cervidil",
      "product_version": "Cervidil (dinoprostone 10 mg vaginal insert), original approval of NDA020411; labelling read is openFDA label version 10, effective 2023-06-02",
      "indication": "Initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labour.",
      "context_id": "maternal:ctx-fda-nda020411-us",
      "jurisdictions": [
        "US"
      ],
      "jurisdiction_note": "United States",
      "authority_id": "core:fda",
      "decision_type": "approval",
      "recall_class": null,
      "submission_id": "NDA020411",
      "pathway": "nda",
      "product_code": null,
      "device_class": null,
      "decision_date": "1995-03-30",
      "valid_to": null,
      "claim_id": "maternal:claim-fda-nda020411-cervidil"
    }
  ],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "contains",
        "label": "Active ingredient (generic name on the label)",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:dinoprostone",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:openfda-label-f3bc9031-0620-4a50-b440-f661cadfeb1d-2026-10-14",
          "locator": "results[0].openfda.generic_name[0]"
        },
        "primary": false,
        "role": "active",
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "related_to",
        "label": "Cervical ripening before induction",
        "clinical_claim_not_fact": false,
        "family": "navigation",
        "other_entity_id": "maternal:induction-of-labour",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": null,
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "part_of",
        "label": "Filed under this front",
        "clinical_claim_not_fact": false,
        "family": "navigation",
        "other_entity_id": "maternal:front-medicines-and-vaccines",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": null,
        "primary": true,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "products/cervidil/",
  "context_path": "api/v1/context/maternal--cervidil.md"
}