United States· US:0480-3472_e70f2946-fc53-487c-b37a-d11ee6751735

Amethyst

A medicinal product containing levonorgestrel; ethinyl estradiol, registered in United States by Teva Pharmaceuticals, Inc..

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedAmethystATC—REGISTER NO.US:0480-3472_e70f2946…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
LEVONORGESTREL; ETHINYL ESTRADIOL
Manufacturer
Teva Pharmaceuticals, Inc.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    0480347224
    1 POUCH in 1 CARTON (0480-3472-24) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK
  • ndc11
    0480-3472-24

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Levonorgestrel; ethinyl estradiol in 14 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All levonorgestrel; ethinyl estradiol products

Authorised across Europe · EMA

The same active substance is authorised in 25 EEA countries. Names it is sold under:

  • Austria · Erlidona, Ethinylestradiol/Levonorgestrel Nextpharma
  • Belgium · Eleonor 20, Lavinia
  • Bulgaria · Три-Регол
  • Czechia · Ebelya, Minisiston
  • Germany · Asumate 20, Asumate 30
  • Denmark · Anastrella, Femicept
  • Spain · Aileva, Anaomi
  • France · Adepal, Asterluna
  • United Kingdom (Northern Ireland) · Ambelina, Elevin
  • Croatia · Adexa
  • Hungary · Rigevidon, Seasonique
  • Ireland · Leonore, Levonorgestrel/ Ethinylestradiol Renata Pharmaceuticals (Ireland)
  • Iceland · Levoethin, Melleva
  • Italy · Egogyn, Lasca
  • Lithuania · Rigevidon, Tri - Regol
  • Luxembourg · Levorichter 30, Lowette
  • Latvia · Rigevidon
  • Netherlands · Ethinylestradiol/Levonorgestrel Ceres Pharma, Ethinylestradiol/Levonorgestrel Focus
  • Norway · Melleva, Microgynon
  • Poland · Levomine, Levomine Mini
  • Portugal · Effilevo, Etinilestradiol + Levonorgestrel Generis
  • Romania · Microgynon, Seasonique
  • Sweden · Anastrella, Leverette 21
  • Slovenia · Stediril-M
  • Slovakia · Ebelya, Seasonique

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/68d18a83-2cd3-4581-bdeb-bc23b6708086
GET /v1/drugs/68d18a83-2cd3-4581-bdeb-bc23b6708086?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "90; 20",
  "substance": "LEVONORGESTREL; ETHINYL ESTRADIOL",
  "productndc": "0480-3472",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "ug/1; ug/1",
  "application_number": "ANDA079218",
  "marketing_category": "ANDA"
}

See everything about levonorgestrel; ethinyl estradiol.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.