{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:pitocin", "owner": "maternal", "kind": "product", "slug": "pitocin", "name": "Pitocin (oxytocin injection)", "aliases": [ "Pitocin" ], "atlases": [ "maternal" ], "summary_plain": "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.", "summary_technical": "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.", "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", "postpartum" ], "care-area": [ "labour-and-birth" ] } }, "payload": { "subtype": "medicine", "model_or_formulation": "Oxytocin injection, USP, 10 USP units per mL (Drugs@FDA also lists 100 units/10 mL and 500 units/50 mL presentations).", "version": "openFDA label version 15, effective 2026-05-05", "intended_use_snapshots": [ "maternal:openfda-label-6e5a66fc-e507-497c-b5ce-44a8c95898ad-2026-10-14" ] }, "content_digest": "40eef8cc28cf9049ca071fef87ba62e4f599f33f37786f3394d0e34e86188c23", "review": { "content_digest": "40eef8cc28cf9049ca071fef87ba62e4f599f33f37786f3394d0e34e86188c23", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-fda-nda018261-pitocin", "owner": "maternal", "subject_entity_id": "maternal:pitocin", "category": "regulatory", "statement": "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.", "context": { "id": "maternal:ctx-fda-nda018261-us", "label": "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_note": "Pregnancy, labour and the time just after birth", "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": [ "Patients covered by the labelled antepartum and postpartum indications" ], "exclusion": [ "Elective induction of labour in a pregnant individual with no medical indication (the label says Pitocin is not indicated for it)" ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "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.", "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-nda018261-2026-10-14", "retrieved_at": "2026-10-14T18:23:44Z", "content_hash": "d7f1d2ec8b5431dbdd558bea2ab69e1a8bb5132db4d821110d88e422e8006f1e", "source_effective_date": "2026-10-13", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-nda018261", "source_type": "regulator", "title": "FDA new drug application NDA018261, PITOCIN: 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=018261", "identifiers": [ { "scheme": "fda-nda", "value": "NDA018261", "normalized_value": "NDA018261", "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-NDA018261.json and the Drugs@FDA page at research/snapshots/mg-fda-daf-018261.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-018261-2026-10-14", "retrieved_at": "2026-10-14T18:30:45Z", "content_hash": "866c9d95b04181d8d13f3ead7dbb987ca5c8f88911466b8b1fa2839ba4587b04", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-nda018261", "source_type": "regulator", "title": "FDA new drug application NDA018261, PITOCIN: 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=018261", "identifiers": [ { "scheme": "fda-nda", "value": "NDA018261", "normalized_value": "NDA018261", "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-NDA018261.json and the Drugs@FDA page at research/snapshots/mg-fda-daf-018261.html.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].indications_and_usage and results[0].boxed_warning", "applicability_note": "openFDA label record, CC0; label version 15.", "snapshot": { "id": "maternal:openfda-label-6e5a66fc-e507-497c-b5ce-44a8c95898ad-2026-10-14", "retrieved_at": "2026-10-14T18:24:04Z", "content_hash": "1b3d6493d2bee7c173d4beab0b6b38e82e16d036133db1a7a84a9e3dec6f6595", "source_effective_date": "2026-05-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-label-6e5a66fc-e507-497c-b5ce-44a8c95898ad", "source_type": "label", "title": "Pitocin drug label (openFDA record, set id 6e5a66fc-e507-497c-b5ce-44a8c95898ad)", "canonical_url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e5a66fc-e507-497c-b5ce-44a8c95898ad", "identifiers": [ { "scheme": "spl-set-id", "value": "6e5a66fc-e507-497c-b5ce-44a8c95898ad", "normalized_value": "6e5a66fc-e507-497c-b5ce-44a8c95898ad", "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 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.", "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.", "public_text": "quote" } } ], "review": { "content_digest": "98eee0db6cce13af6f352594ce315568f4665eb2bf5bdd6ac94b4bc9effabc3a", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-fda-nda018261-pitocin.json" } ], "decisions": [ { "type": "regulatory_decision", "id": "maternal:regdec-fda-nda018261", "product_id": "maternal:pitocin", "product_version": "Pitocin (oxytocin injection, USP), original approval of NDA018261; labelling read is openFDA label version 15, effective 2026-05-05", "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.", "context_id": "maternal:ctx-fda-nda018261-us", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "approval", "recall_class": null, "submission_id": "NDA018261", "pathway": "nda", "product_code": null, "device_class": null, "decision_date": "1980-11-19", "valid_to": null, "claim_id": "maternal:claim-fda-nda018261-pitocin" } ], "milestones": [], "relationships": { "outgoing": [ { "predicate": "contains", "label": "Active ingredient (generic name on the label)", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "maternal:oxytocin", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "maternal:openfda-label-6e5a66fc-e507-497c-b5ce-44a8c95898ad-2026-10-14", "locator": "results[0].openfda.generic_name[0]" }, "primary": false, "role": "active", "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/pitocin/", "context_path": "api/v1/context/maternal--pitocin.md" }