Medicine
Amethyst 20 mcg/90 mcg tablet
Amethyst 20 mcg/90 mcg tablet is a prescription medicine containing Ethinyl estradiol and Levonorgestrel for oral use, marketed by Teva 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
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)
- Ethinyl estradiol and Levonorgestrel
- Brand
- Amethyst
- Strength
- 20 mcg/90 mcg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 pouch
- Marketing authorisation holder
- Teva Pharmaceuticals
- Manufacturer
- Teva Pharmaceuticals
- 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
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 March 2023
- Identifiers
- RxCUI 722152, 751553, 1112715DailyMed set ID 99073fe0-eac8-44dd-abe6-623fa67d9e79NDC 0480-3472Application ANDA079218
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 |
|---|---|---|---|
| 1 pouch in 1 carton / 1 blister pack in 1 pouch / 28 tablet in 1 blister pack | 0480-3472-24 | Teva Pharmaceuticals | 1 March 2023 |
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 10 May 1982 | 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 Ethinyl estradiol and Levonorgestrel 20 mcg/90 mcg tablet.
Other strengths and forms of Ethinyl estradiol and Levonorgestrel
Clinical summary
Ethinyl estradiol and Levonorgestrel is a fixed-dose combination of an estrogen, a progestin and a progestin-containing intrauterine system indicated by females of reproductive potential to prevent pregnancy. MedsAcross supplies Ethinyl estradiol and Levonorgestrel 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 LevonorgestrelFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- levonorgestrel and ethinyl estradiol prescribing information (Acella Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Amethyst 20 mcg/90 mcg 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.