Medicine
Nextstellis kit
Nextstellis kit is a prescription medicine containing Drospirenone and Estetrol, marketed by Mayne Pharma, 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Drospirenone and Estetrol
- Brand
- Nextstellis
- Dosage form
- Kit
- Packs
- 1 blister pack
- Marketing authorisation holder
- Mayne Pharma
- Manufacturer
- Mayne Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G03 Sex hormones and fertility medicines
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 April 2021
- Identifiers
- RxCUI 748797, 2539032, 2539033 +1DailyMed set ID c5270073-d083-4109-ae4b-156986175e0aNDC 51862-258Application NDA214154
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 blister pack in 1 carton / 1 kit in 1 blister pack * 24 tablet, film coated in 1 blister pack * 4 tablet, film coated in 1 blister pack | 51862-258-01 | Mayne Pharma | 16 April 2021 |
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.
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
Clinical summary
Drospirenone and Estetrol is a fixed-dose combination medicine indicated by females of reproductive potential to prevent pregnancy. It is available as kits. MedsAcross supplies Drospirenone and Estetrol 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 Drospirenone and EstetrolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nextstellis prescribing information (Mayne Pharma) · U.S. National Library of Medicine, DailyMed
- Drovelis: European public assessment report (EPAR) · European Medicines Agency
- Lydisilka: European public assessment report (EPAR) · European Medicines Agency
Need Nextstellis kit 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.