Medicine
Orquidea 0.35 mg tablet
Orquidea 0.35 mg tablet is a prescription medicine containing Norethindrone for oral use, marketed by Xiromed, 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
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Norethindrone
- Brand
- Orquidea
- Strength
- 0.35 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 3 pouches
- Marketing authorisation holder
- Xiromed
- Manufacturer
- Xiromed
- Origin register
- US FDA, United States
- Storage
- Store at 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
- 29 January 2025
- Identifiers
- DailyMed set ID 6e9f61a1-93ff-291a-bea8-9307a3b0378eNDC 70700-316Application ANDA201483
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 blister pack in 1 pouch / 28 tablet in 1 blister pack | 70700-316-85 | Xiromed | 29 January 2025 |
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 2 January 1973 | 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
Alternatives
Other makers and brands of Norethindrone 0.35 mg tablet.
- Norethindrone 0.35 mg tabletAvailable on request—US FDA6 packs
- Incassia 0.35 mg tabletAvailable on requestAurobindo PharmaIndiaUS FDA6 packs
- Emzahh 0.35 mg tabletAvailable on requestAurobindo PharmaIndiaUS FDA3 packs
- Errin 0.35 mg tabletAvailable on requestDr. Reddy's LaboratoriesIndiaUS FDA2 packs
- Affodel 0.35 mg tabletAvailable on requestNaariUS FDA1 pack
- Camila 0.35 mg tabletAvailable on requestDr. Reddy's LaboratoriesIndiaUS FDA1 pack
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 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
- Nora BE prescribing information (Teva Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Orquidea 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.