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Zafemy 35 mcg/150 mcg per day transdermal patch

Ethinyl estradiol and Norelgestromin · Transdermal · Amneal Pharmaceuticals
Available on requestPrescription onlyUS FDA

Zafemy 35 mcg/150 mcg per day transdermal patch is a prescription medicine containing Ethinyl estradiol and Norelgestromin for transdermal use, marketed by Amneal 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

Available on request

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
Zafemy
Strength
35 mcg/150 mcg per day
Dosage form
Transdermal patch
Route
Transdermal
Packs
3 pouches
Marketing authorisation holder
Amneal Pharmaceuticals
Manufacturers
Amneal PharmaceuticalsAvKAREBryant Ranch Prepack
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), excursions permitted between 15° to 30°C (59° to 86°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
28 June 2020
Identifiers
RxCUI 1534809, 2531285DailyMed set ID 77230a20-4269-4abf-ae2a-ac5ccafef565, fbbd12dd-c538-2869-e053-6294a90a1a38, 5ee34c07-65af-42b8-a98f-e299ff90a8a1NDC 72162-2220, 42291-930, 65162-358Application ANDA213950

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
3 pouch in 1 carton / 1 patch in 1 pouch / 7 d in 1 patch65162-358-03Amneal Pharmaceuticals30 June 2020
3 pouch in 1 carton / 1 patch in 1 pouch / 7 d in 1 patch42291-930-03AvKARE15 May 2023
3 pouch in 1 carton / 1 patch in 1 pouch / 7 d in 1 patch72162-2220-1Bryant Ranch Prepack5 January 2024

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 20 November 2001Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
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 Norelgestromin 35 mcg/150 mcg per day transdermal patch.

Compare all 2

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 Norelgestromin

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

Data sources

Need Zafemy 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.