Active substance
Oxytocin
- SFDA 8
- US FDA 11
- Health Canada 3
- WHO EML 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| GYNOCIN 10 IU/ml solution for injection | 10 IU/ml | Solution for injection · Parenteral use | 6 Ampoule | SAR 23.80 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| GYNOCIN 10 IU/ml solution for injection | 10 IU/ml | Solution for injection · Parenteral use | 6 Ampoule | SAR 11.90 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Gynocin | 5 IU/ml | Solution for injection · Parenteral use | 25 Ampoule | SAR 49.60 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Gynocin | 10 IU/ml | Solution for injection · Parenteral use | 25 Ampoule | SAR 99.15 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Ofost | 5 IU/ml | Solution for injection/infusion · Intramuscular and intravenous use | 10 Ampoule | SAR 19.80 | Generic · Prescription | JSC GRINDEKS | Valid |
| Oxytocin EVER Pharma | 10 IU/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 19.80 | Generic · Prescription | EVER Neuro Pharma GmbH | Valid |
| SYNTOCINON 5 IU injection | 5 IU/ml | Solution for injection/concentrate for solution for infusion · Intravenous use | 5 Ampoule | SAR 11.65 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
| SYNTOCINON 5 IU injection | 5 IU/ml | Solution for injection/concentrate for solution for infusion · Intravenous use | 5 Ampoule | SAR 11.65 | NCE · Prescription | Mylan Pharma GmbH | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANESTHESIA-OBSTETRIC USE/ FACILITATING UTERINE CONTRACTION; MATERNAL AND CHILD HEALTHCARE- POSTPARTUM HEMORRHAGE
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML); 100USP UNITS/10ML (10USP UNITS/ML) | injectable · injection | HIKMA PHARMS | Prescription | 29 Apr 1980 |
| OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML); 100USP UNITS/10ML (10USP UNITS/ML); 300USP UNITS/30ML (10USP UNITS/ML) | injectable · injection | FRESENIUS KABI USA | Prescription | 9 Jul 1980 |
| PITOCIN | 10USP UNITS/ML (10USP UNITS/ML); 100USP UNITS/10ML (10USP UNITS/ML); 500USP UNITS/50ML (10USP UNITS/ML) | injectable · injection | PH HEALTH | Prescription | 19 Nov 1980 |
| OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML) | injectable · injection | HIKMA FARMACEUTICA | Prescription | 13 Feb 2013 |
| OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML); 100USP UNITS/10ML (10USP UNITS/ML) | injectable · injection | SAGENT PHARMS INC | Prescription | 13 Jul 2018 |
| SYNTOCINON | 10USP UNITS/ML | injectable · injection | NOVARTIS | Discontinued | 17 Apr 1980 |
| OXYTOCIN 5 USP UNITS IN DEXTROSE 5% | 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | ABBOTT | Discontinued | 29 Mar 1985 |
| OXYTOCIN 20 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | ABBOTT | Discontinued | 29 Mar 1985 |
| OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | ABBOTT | Discontinued | 29 Mar 1985 |
| OXYTOCIN | 10USP UNITS/ML (10USP UNITS/ML); 100USP UNITS/10ML (10USP UNITS/ML) | injectable · injection | DR REDDYS | Discontinued | 24 Jan 2008 |
| SYNTOCINON | 40USP UNITS/ML | solution · nasal | RTRX | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| OXYTOCIN INJECTION USP | 00497398 | 10 UNIT / ML | SOLUTION · INTRAVENOUS; INTRAMUSCULAR | PFIZER CANADA ULC |
| OXYTOCIN INJECTION, USP | 02139561 | 10 UNIT / ML | SOLUTION · INTRAMUSCULAR; INTRAVENOUS | FRESENIUS KABI CANADA LTD |
| OXYTOCIN INJECTION, USP | 02550199 | 10 UNIT / ML | SOLUTION · INTRAMUSCULAR; INTRAVENOUS | HIKMA CANADA LIMITED |
WHO WHO Model List of Essential Medicines (2025)
- 22.3. Uterotonics · core
Postpartum haemorrhage
Parenteral > General injections > unspecified: 10 IU per mL
Safety signals and safety-related labeling changes
- US FDA 20 Sep 2022 OXYTOCIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.