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United States· US:75834-129_4ffa902e-2cf8-4160-ba1e-f27e48b8e502

Norethindrone Acetate and Ethinyl Estradiol

A medicinal product containing norethindrone acetate; ethinyl estradiol, registered in United States by Nivagen 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…normalisedNorethindrone Acetate and Ethinyl Est…ATC—REGISTER NO.US:75834-129_4ffa902e…PACKS LISTED4CHECKEDAugust 23, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
Manufacturer
Nivagen 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
August 23, 2026

Packs & prices · 4

  • ndc11
    7583412929
    3 BLISTER PACK in 1 CARTON (75834-129-29) / 28 TABLET in 1 BLISTER PACK (75834-129-84)
  • ndc11
    7583412990
    90 TABLET in 1 BOTTLE (75834-129-90)
  • ndc11
    75834-129-29
  • ndc11
    75834-129-90

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/ff6ba47c-e034-4a30-95a9-76413c46e8be
GET /v1/drugs/ff6ba47c-e034-4a30-95a9-76413c46e8be?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": ".0025; .5",
  "substance": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
  "productndc": "75834-129",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA203435",
  "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.