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Aurovela 1/20 20 mcg/1 mg tablet

Ethinyl estradiol and Norethindrone · Oral · Aurobindo Pharma
Available on requestPrescription onlyUS FDAIndian manufacturer

Aurovela 1/20 20 mcg/1 mg tablet is a prescription medicine containing Ethinyl estradiol and Norethindrone for oral use, marketed by Aurobindo 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20 o to 25 • C (68 o to 77 • F).

Key facts

Active ingredient (INN)
Ethinyl estradiol and Norethindrone
Brand
Aurovela 1/20
Strength
20 mcg/1 mg
Dosage form
Tablet
Route
Oral
Packs
5 pouches, 3 pouches
Marketing authorisation holder
Aurobindo Pharma
Manufacturer
Aurobindo PharmaIndia
Origin register
US FDA, United States
Storage
Store at 20 o to 25 • C (68 o to 77 • F).
Cold chain
Not required on record
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
16 June 2017
Identifiers
RxCUI 1358762, 1358776, 1927366DailyMed set ID 6765becf-7b51-4f33-ac13-70fcd01decf7NDC 65862-939Application ANDA207506

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

PackCodeLabelerMarketed since
5 pouch in 1 carton / 1 blister pack in 1 pouch / 21 tablet in 1 blister pack65862-939-54Aurobindo PharmaIndia16 June 2017
3 pouch in 1 carton / 1 blister pack in 1 pouch / 21 tablet in 1 blister pack65862-939-88Aurobindo PharmaIndia16 June 2017

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 30 April 1973Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

Alternatives

Other makers and brands of Ethinyl estradiol and Norethindrone 20 mcg/1 mg tablet.

Compare all 2

Other strengths and forms of Ethinyl estradiol and Norethindrone

Clinical summary

Ethinyl 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 Ethinyl 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 Ethinyl estradiol and Norethindrone

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Aurovela 1/20 20 mcg/1 mg tablet 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.