Medicine
Prepidil 0.0166667% vaginal gel
Prepidil 0.0166667% vaginal gel is a prescription medicine containing Dinoprostone for vaginal use, marketed by Pharmacia & Upjohn, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
PREPIDIL Gel needs to be stored under continuous refrigeration (36° to 46°F…
Key facts
- Active ingredient (INN)
- Dinoprostone
- Brand
- Prepidil
- Strength
- 0.0166667%
- Dosage form
- Vaginal gel
- Route
- Vaginal
- Packs
- 1 syringe
- Marketing authorisation holder
- Pharmacia & Upjohn
- Manufacturer
- Pharmacia & Upjohn
- Origin register
- US FDA, United States
- Storage
- PREPIDIL Gel needs to be stored under continuous refrigeration (36° to 46°F, 2° to 8°C).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G02AD02 Dinoprostone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 December 1992
- Identifiers
- RxCUI 208397, 309922DailyMed set ID ab03de5b-782c-4f81-a8dc-7ef9969dd0cfNDC 0009-3359Application NDA019617
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 syringe in 1 carton / 3 g in 1 syringe | 0009-3359-01 | Pharmacia & Upjohn | 11 December 2019 |
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 23 August 1977 | 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 Dinoprostone
Clinical summary
Dinoprostone is a prostaglandin analog indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction. It is available as vaginal gel and vaginal inserts. MedsAcross supplies Dinoprostone 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 DinoprostoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Prepidil prescribing information (Pharmacia & Upjohn) · U.S. National Library of Medicine, DailyMed
Need Prepidil 0.0166667% vaginal gel 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.