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United States· US:0378-7280_e450353d-021c-b48d-d1ea-0787a1561ae2

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

A medicinal product containing ethinyl estradiol; norethindrone acetate, registered in United States by Mylan 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:0378-7280_e450353d…PACKS LISTED2CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about ethinyl estradiol; norethindrone acetateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Manufacturer
Mylan 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
    0378728053
    3 POUCH in 1 CARTON (0378-7280-53) / 1 BLISTER PACK in 1 POUCH (0378-7280-85) / 21 TABLET in 1 BLISTER PACK
  • ndc11
    0378-7280-53

Regulatory notes

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

Same medicine, other countries

Ethinyl estradiol; norethindrone acetate in 4 other countries

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

All ethinyl estradiol; norethindrone acetate 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/5a06d423-1375-47d1-aaec-c353644d86e3
GET /v1/drugs/5a06d423-1375-47d1-aaec-c353644d86e3?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": ".02; 1",
  "substance": "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE",
  "productndc": "0378-7280",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA202771",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

See everything about ethinyl estradiol; norethindrone acetate.

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.

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