Medicine
Progesterone 500 mg/10 mL injection
Progesterone 500 mg/10 mL injection is a generic prescription medicine for intramuscular use, made by 3 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
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Progesterone
- Brand
- Sold under the generic name
- Strength
- 500 mg/10 mL
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 10 mL, 1 vial of 10 mL
- Manufacturers
- EugiaIndiaFresenius KabiXiromed
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G03DA04 Progesterone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 July 2001
- Identifiers
- RxCUI 312644DailyMed set ID 7d19df3b-94ed-4681-beae-9caaf137d014, a479b395-1e1a-4d2a-8feb-68a15c47225f, dcfa4050-d142-b774-369f-8a421eb23c62NDC 55150-306, 63323-261, 70700-286Application ANDA210965, ANDA075906, ANDA215634
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 |
|---|---|---|---|
| 10 mL in 1 vial, multi-dose | 55150-306-10 | EugiaIndia | 6 December 2018 |
| 1 vial, multi-dose in 1 carton / 10 mL in 1 vial, multi-dose | 63323-261-10 | Fresenius Kabi | 19 July 2001 |
| 10 mL in 1 vial, multi-dose | 70700-286-22 | Xiromed | 29 March 2022 |
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 1 November 1974 | 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 Progesterone
Clinical summary
Progesterone is a progesterone indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency, among other approved uses. MedsAcross supplies Progesterone 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 ProgesteroneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Crinone prescribing information (Allergan) · U.S. National Library of Medicine, DailyMed
Need Progesterone 500 mg/10 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.