Medicine
Oxytocin 10 units/mL injection
Oxytocin 10 units/mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not permit to freeze. Store at 20º to 25ºC (68º to 77ºF).
Key facts
- Active ingredient (INN)
- Oxytocin
- Brand
- Sold under the generic name
- Strength
- 10 units/mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 25 vials, 10 vials, 5 vials and 6 more
- Manufacturers
- Fresenius KabiWest-Ward PharmaceuticalsCardinal HealthRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Do not permit to freeze. Store at 20º to 25ºC (68º to 77ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- H01BB02 Oxytocin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 August 2000
- Identifiers
- RxCUI 238013, 1791721DailyMed set ID d16a48c5-6b71-40a0-bcda-204f043fe832, 6d7d1280-f286-4f39-89f3-2b96571810e6, 4c4c4b69-8bf7-472c-aafe-29805ba5c965 +3NDC 0143-9743, 63323-012, 65219-021 +3Application ANDA200219, NDA018248
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-012-07 | Fresenius Kabi | 10 August 2000 |
| 25 vial, multi-dose in 1 tray / 10 mL in 1 vial, multi-dose | 63323-012-10 | Fresenius Kabi | 10 August 2000 |
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-012-11 | Fresenius Kabi | 10 August 2000 |
| 10 vial, multi-dose in 1 tray / 30 mL in 1 vial, multi-dose | 63323-012-30 | Fresenius Kabi | 10 August 2000 |
| 25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 65219-021-01 | Fresenius Kabi | 6 May 2024 |
| 25 vial in 1 carton / 10 mL in 1 vial | 0143-9742-25 | West-Ward Pharmaceuticals | 13 February 2013 |
| 25 vial in 1 carton / 1 mL in 1 vial | 0143-9743-25 | West-Ward Pharmaceuticals | 13 February 2013 |
| 5 vial in 1 bag / 1 mL in 1 vial | 55154-9584-5 | Cardinal Health | 8 November 2019 |
| 25 vial in 1 tray / 1 mL in 1 vial | 70518-4233-0 | Remedyrepack | 18 November 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 17 April 1980 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Oxytocin
Clinical summary
Oxytocin is an oxytocic indicated for the medical rather than the elective induction of labor, among other approved uses. It is available as injection for intravenous and intramuscular use. MedsAcross supplies Oxytocin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about OxytocinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Oxytocin prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Oxytocin 10 units/mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.