Pitocin (oxytocin injection)

Context Pregnant individuals before birth and women in the third stage of labour and after birth, US label for Pitocin (NDA018261)

Recipient

Maternal

Population

The antepartum uses on the US label (initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery: (1) induction of labour in patients with a medical indication, such as Rh problems, maternal diabetes or pre-eclampsia at or near term; (2) stimulation or reinforcement of labour in selected cases of uterine inertia; (3) adjunctive therapy in incomplete or inevitable abortion) and the postpartum use (producing uterine contractions in the third stage of labour and controlling postpartum bleeding or haemorrhage). The label says the product is not indicated for elective induction of labour.

Care setting

Not stated in the source

Geography

United States (FDA-approved labelling)

Life stage

Pregnancy, labour and the time just after birth

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 NDA018261 for Pitocin (oxytocin injection) on 1980-11-19, classified Type 5, new formulation or new manufacturer; the current sponsor in Drugs@FDA is PH Health and the labelling is by Par Health USA, LLC. The US label (version 15, effective 2026-05-05) lists use before birth to start or improve uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery, and use after birth to produce contractions in the third stage of labour and to control postpartum bleeding. The antepartum indications are (1) induction of labour in patients with a medical indication such as Rh problems, maternal diabetes or pre-eclampsia at or near term, (2) stimulation or reinforcement of labour in selected cases of uterine inertia, and (3) adjunctive therapy in incomplete or inevitable abortion. A boxed notice says Pitocin is not indicated for elective induction of labour.

  Applies to Maternal

  • The antepartum uses on the US label (initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery: (1) induction of labour in patients with a medical indication, such as Rh problems, maternal diabetes or pre-eclampsia at or near term; (2) stimulation or reinforcement of labour in selected cases of uterine inertia; (3) adjunctive therapy in incomplete or inevitable abortion) and the postpartum use (producing uterine contractions in the third stage of labour and controlling postpartum bleeding or haemorrhage). The label says the product is not indicated for elective induction of labour.
  • Not stated in the source
  • United States (FDA-approved labelling)
  • Pregnancy, labour and the time just after birth
  • 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; it is not the date of the current label, which has changed many times since (the application lists supplements for labelling and manufacturing). The indication wording is from the openFDA copy of the current label and was not compared with the DailyMed page. Approval means FDA found the product acceptable for the labelled uses in the United States; it is not a recommendation to use it for any woman, and labelled uses differ by country. Three other label set ids exist for the same application and were not read.

  Last checked

  2026-10-14

  Next evidence check due

  Not scheduled

  Sources and citations (3)

  1. Supports FDA new drug application NDA018261, PITOCIN: 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: NDA018261

     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

     d7f1d2ec8b5431dbdd558bea2ab69e1a8bb5132db4d821110d88e422e8006f1e

     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-NDA018261.json and the Drugs@FDA page at research/snapshots/mg-fda-daf-018261.html.

  2. Supports FDA new drug application NDA018261, PITOCIN: 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: NDA018261

     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

     2026-10-14T18:30:45Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     866c9d95b04181d8d13f3ead7dbb987ca5c8f88911466b8b1fa2839ba4587b04

     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-NDA018261.json and the Drugs@FDA page at research/snapshots/mg-fda-daf-018261.html.

  3. Supports Pitocin drug label (openFDA record, set id 6e5a66fc-e507-497c-b5ce-44a8c95898ad)

     Label · U.S. Food and Drug Administration (openFDA drug label endpoint) · Edition openFDA drug label record, label effective 20260505, 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: 6e5a66fc-e507-497c-b5ce-44a8c95898ad

     Locator

     results[0].indications_and_usage and results[0].boxed_warning

     How it applies

     openFDA label record, CC0; label version 15.

     Retrieved

     2026-10-14T18:24:04Z

     Source effective date

     2026-05-05

     Source state

     Current

     Snapshot hash

     1b3d6493d2bee7c173d4beab0b6b38e82e16d036133db1a7a84a9e3dec6f6595

     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-6e5a66fc-e507-497c-b5ce-44a8c95898ad.json.