Medicine
Xulane 35 mcg/150 mcg per day transdermal patch
Xulane 35 mcg/150 mcg per day transdermal patch is a prescription medicine containing Ethinyl estradiol and Norelgestromin for transdermal use, marketed by Mylan Pharmaceuticals, 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 store in the refrigerator or freezer. Store at 20° to 25°C (68° to…
Key facts
- Active ingredient (INN)
- Ethinyl estradiol and Norelgestromin
- Brand
- Xulane
- Strength
- 35 mcg/150 mcg per day
- Dosage form
- Transdermal patch
- Route
- Transdermal
- Packs
- 3 pouches
- Marketing authorisation holder
- Mylan Pharmaceuticals
- Manufacturers
- Mylan PharmaceuticalsA-S Medication Solutions
- Origin register
- US FDA, United States
- Storage
- Do not store in the refrigerator or freezer. Store at 20° to 25°C (68° to 77°F). Store patches in their protective pouches.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G03AA13 Ethinyl estradiol and Norelgestromin
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 April 2014
- Identifiers
- RxCUI 1534809, 1536586DailyMed set ID adcf17ef-e60b-48a4-9478-3998dab2bbbd, f7848550-086a-43d8-8ae5-047f4b9e4382NDC 50090-1683, 0378-3340Application ANDA200910
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 |
|---|---|---|---|
| 3 pouch in 1 carton / 1 patch in 1 pouch / 7 d in 1 patch | 0378-3340-53 | Mylan Pharmaceuticals | 16 April 2014 |
| 3 pouch in 1 carton / 1 d in 1 pouch | 50090-1683-0 | A-S Medication Solutions | 6 February 2015 |
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
Alternatives
Other makers and brands of Ethinyl estradiol and Norelgestromin 35 mcg/150 mcg per day transdermal patch.
Other strengths and forms of Ethinyl estradiol and Norelgestromin
Clinical summary
Ethinyl estradiol and Norelgestromin is a fixed-dose combination of an estrogen and a progestin. It is available as transdermal patches. MedsAcross supplies Ethinyl estradiol and Norelgestromin 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 Ethinyl estradiol and NorelgestrominFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gwyn Lo prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
- Evra: European public assessment report (EPAR) · European Medicines Agency
Need Xulane 35 mcg/150 mcg per day transdermal patch 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.