Cervidil (dinoprostone vaginal insert)

Context 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

Pregnancy at or near term

Gestational age

Not reported

Postnatal age

Not reported

Follow-up

Not applicable (regulatory context)

• Regulatory Evidence stage not applicable Certainty not assessed

  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.

  Applies to Maternal

  • 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.
  • Not stated in the source
  • United States (FDA-approved labelling)
  • Pregnancy at or near term
  • Gestational age Not reported
  • Postnatal age Not reported

  Follow-up Not applicable (regulatory context)

  Certainty method

  Not assessed

  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.

  Last checked

  2026-10-14

  Next evidence check due

  Not scheduled

  Sources and citations (3)

  1. Supports FDA new drug application NDA020411, CERVIDIL: openFDA Drugs@FDA record and Drugs@FDA approval history page

     Regulator · 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. · NDA: NDA020411

     Locator

     results[0].submissions: original submission (ORIG 1) with status AP

     How it applies

     openFDA drugsfda JSON, CC0.

     Retrieved

     2026-10-14T18:23:44Z

     Source effective date

     2026-10-13

     Source state

     Current

     Snapshot hash

     efe6b77bfc1afed8718173a9d1f6ccbcab641d9cfde40ac97f52e9676bc1c05a

     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.

  2. Supports FDA new drug application NDA020411, CERVIDIL: openFDA Drugs@FDA record and Drugs@FDA approval history page

     Regulator · 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. · NDA: NDA020411

     Locator

     Original Approvals or Tentative Approvals: action date, submission and classification

     How it applies

     Drugs@FDA overview page; FDA website content is not copyrighted.

     Retrieved

     2026-10-14T18:30:46Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     cc140ad1727ce0984270a9a51fe839f559a2c276f8a795d280c0151970eba772

     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.

  3. Supports CERVIDIL drug label (openFDA record, set id f3bc9031-0620-4a50-b440-f661cadfeb1d)

     Label · 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. · SPL set id: f3bc9031-0620-4a50-b440-f661cadfeb1d

     Locator

     results[0].indications_and_usage

     How it applies

     openFDA label record, CC0; label version 10.

     Retrieved

     2026-10-14T18:24:06Z

     Source effective date

     2023-06-02

     Source state

     Current

     Snapshot hash

     0f4a41c3fc1716760af22915d3dd8267b30998f3a297aa051e7da9421e05a9a9

     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.