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Medicine

Incassia 0.35 mg tablet

Norethindrone · Oral · Aurobindo Pharma
Available on requestPrescription onlyUS FDAIndian manufacturer

Incassia 0.35 mg tablet is a prescription medicine containing 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 controlled room temperature 20° to 25°C (68° to 77° F).

Key facts

Active ingredient (INN)
Norethindrone
Brand
Incassia
Strength
0.35 mg
Dosage form
Tablet
Route
Oral
Packs
1 blister pack, 3 blister pack, 6 blister pack and 3 more
Marketing authorisation holder
Aurobindo Pharma
Manufacturer
Aurobindo PharmaIndia
Origin register
US FDA, United States
Storage
Store at controlled room temperature 20° to 25°C (68° to 77° F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
G03AC01 Norethindrone
HS code (indicative)
3004.39Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
23 September 2016
Identifiers
RxCUI 198042, 748961, 2052064DailyMed set ID 0b87cef0-610c-469d-92ba-4007f4bc3878NDC 65862-925Application ANDA207304

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
1 blister pack in 1 carton / 1 tablet in 1 blister pack65862-925-28Aurobindo PharmaIndia23 September 2016
3 blister pack in 1 carton / 1 tablet in 1 blister pack65862-925-85Aurobindo PharmaIndia23 September 2016
6 blister pack in 1 carton / 1 tablet in 1 blister pack65862-925-86Aurobindo PharmaIndia23 September 2016
1 pouch in 1 carton / 1 tablet in 1 pouch65862-925-87Aurobindo PharmaIndia23 September 2016
3 pouch in 1 carton / 1 tablet in 1 pouch65862-925-88Aurobindo PharmaIndia23 September 2016
6 pouch in 1 carton / 1 tablet in 1 pouch65862-925-92Aurobindo PharmaIndia23 September 2016

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 2 January 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 Norethindrone 0.35 mg tablet.

Compare all 11

Other strengths and forms of Norethindrone

Clinical summary

Norethindrone is a progestin indicated for the prevention of pregnancy. It is available as tablets for oral use. MedsAcross supplies 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 Norethindrone

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

Data sources

Need Incassia 0.35 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.