United States· US:82804-172_56e91ad4-f31b-494d-9e75-6dd4f396779c

Junel

A medicinal product containing norethindrone acetate; ethinyl estradiol, registered in United States by Proficient Rx LP.

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…normalisedJunelATC—REGISTER NO.US:82804-172_56e91ad4…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
Manufacturer
Proficient Rx LP
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
    8280417221
    3 POUCH in 1 CARTON (82804-172-21) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
  • ndc11
    82804-172-21

Regulatory notes

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

Same medicine, other countries

Norethindrone acetate; ethinyl estradiol in 4 other countries

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

All norethindrone acetate; ethinyl estradiol products

Authorised across Europe · EMA

The same active substance is authorised in 1 EEA country. Names it is sold under:

  • United Kingdom (Northern Ireland) · Brevinor, Norimin

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/05dd3dc0-c259-4b7a-83e6-17a38c9ba48c
GET /v1/drugs/05dd3dc0-c259-4b7a-83e6-17a38c9ba48c?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": "1; 20",
  "substance": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
  "productndc": "82804-172",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1; ug/1",
  "application_number": "ANDA076380",
  "marketing_category": "ANDA"
}

See everything about norethindrone acetate; 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.