Medicine
CombiPatch (estradiol/norethindrone acetate transdermal system) 0.05 mg/0.25 mg per day transdermal patch
CombiPatch (estradiol/norethindrone acetate transdermal system) 0.05 mg/0.25 mg per day transdermal patch is a prescription medicine containing Estradiol and Norethindrone for transdermal use, marketed by Noven Therapeutics, 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
Store CombiPatch in the refrigerator at 36℉ to 46℉ (2℃ to 8℃). Store the…
Key facts
- Active ingredient (INN)
- Estradiol and Norethindrone
- Brand
- CombiPatch (estradiol/norethindrone acetate transdermal system)
- Strength
- 0.05 mg/0.25 mg per day
- Dosage form
- Transdermal patch
- Route
- Transdermal
- Packs
- 8 pouches
- Marketing authorisation holder
- Noven Therapeutics
- Manufacturer
- Noven Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store CombiPatch in the refrigerator at 36℉ to 46℉ (2℃ to 8℃). Store the systems in the sealed foil pouch. Do not store the system in areas where extreme temperatures can occur.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 August 1998
- Identifiers
- RxCUI 1251493, 1251495, 1251499 +1DailyMed set ID 83198ef1-11c4-11e4-9191-0800200c9a66NDC 68968-0525Application NDA020870
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 |
|---|---|---|---|
| 8 pouch in 1 carton / 1 patch in 1 pouch / 3.5 d in 1 patch | 68968-0525-8 | Noven Therapeutics | 7 August 1998 |
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 7 August 1998 | 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 Estradiol and Norethindrone
Clinical summary
Estradiol and Norethindrone is a fixed-dose combination of an estrogen and a progestin indicated in a woman with a uterus for treatment of moderate to severe vasomotor symptoms due to menopause. MedsAcross supplies Estradiol and Norethindrone 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 Estradiol and NorethindroneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CombiPatch (estradiol/norethindrone acetate transdermal system) prescribing information (Noven Therapeutics) · U.S. National Library of Medicine, DailyMed
Need CombiPatch (estradiol/norethindrone acetate transdermal system) 0.05 mg/0.25 mg 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.