# Pitocin (oxytocin injection) Product · id `maternal:pitocin` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: Pitocin Browse, life stage: Childbirth; Postpartum Browse, care area: Labour and birth ## In plain language Pitocin is a brand of oxytocin injection with a US label from Par Health USA, approved in the United States under application NDA018261. Its US label says it is for starting or improving contractions before birth when that is desirable and considered suitable for reasons of the mother's or baby's health, in order to achieve vaginal delivery, and after birth to produce contractions in the third stage of labour and to control bleeding. A boxed notice on the label says it is not indicated for elective induction of labour, which means induction for someone with no medical reason for it. ## Technical summary US reference product for oxytocin injection. openFDA label set id 6e5a66fc-e507-497c-b5ce-44a8c95898ad, version 15, effective 2026-05-05, manufacturer Par Health USA, LLC, route intravenous; the Drugs@FDA record for NDA018261 lists strengths of 10 USP units/mL (the reference standard), 100 units/10 mL and 500 units/50 mL, and three other label set ids for the same application, which were not read. Labelled uses differ by country and only the US label was read. The label wording is the dataset's copy as of the date fetched, not the current DailyMed label. ## Claims, with the population each applies to ## 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) ### 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. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: 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) - 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 - Sources: 1. Supports: FDA new drug application NDA018261, PITOCIN: openFDA Drugs@FDA record and Drugs@FDA approval history page (Regulator, 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.) Locator: results\[0\].submissions: original submission (ORIG 1) with status AP. Retrieved 2026-10-14T18:23:44Z. Source state: Current. Snapshot hash: d7f1d2ec8b5431dbdd558bea2ab69e1a8bb5132db4d821110d88e422e8006f1e. How it applies: openFDA drugsfda JSON, CC0. 2. Supports: FDA new drug application NDA018261, PITOCIN: openFDA Drugs@FDA record and Drugs@FDA approval history page (Regulator, 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.) Locator: Original Approvals or Tentative Approvals: action date, submission and classification. Retrieved 2026-10-14T18:30:45Z. Source state: Current. Snapshot hash: 866c9d95b04181d8d13f3ead7dbb987ca5c8f88911466b8b1fa2839ba4587b04. How it applies: Drugs@FDA overview page; FDA website content is not copyrighted. 3. Supports: Pitocin drug label (openFDA record, set id 6e5a66fc-e507-497c-b5ce-44a8c95898ad) (Label, 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.) Locator: results\[0\].indications\_and\_usage and results\[0\].boxed\_warning. Retrieved 2026-10-14T18:24:04Z. Source state: Current. Snapshot hash: 1b3d6493d2bee7c173d4beab0b6b38e82e16d036133db1a7a84a9e3dec6f6595. How it applies: openFDA label record, CC0; label version 15. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-nda018261` - Product: Pitocin (oxytocin injection) (`maternal:pitocin`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 1980-11-19 - Product version: Pitocin (oxytocin injection, USP), original approval of NDA018261; labelling read is openFDA label version 15, effective 2026-05-05 - Pathway: NDA - Submission: NDA018261 - Indication: Before birth: 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; the label lists induction of labour in patients with a medical indication, stimulation or reinforcement of labour, and adjunctive therapy in incomplete or inevitable abortion; after birth: to produce uterine contractions in the third stage of labour and to control postpartum bleeding or haemorrhage. Not indicated for elective induction of labour. - Jurisdictions: United States; note: United States - Applies to: 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) - Basis: claim `maternal:claim-fda-nda018261-pitocin` ## Connected pages - Active ingredient (generic name on the label): Oxytocin (`maternal:oxytocin`) - Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`) ## Provenance Content hash: 40eef8cc28cf9049ca071fef87ba62e4f599f33f37786f3394d0e34e86188c23 Last substantive edit: 2026-10-14 Evidence last checked: 2026-10-14