United States· US:68462-504_299fb286-ee60-4950-8315-d310c6ce29cd

Hailey 1.5/30

A medicinal product containing norethindrone acetate; ethinyl estradiol, registered in United States by Glenmark Pharmaceuticals Inc., USA.

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…normalisedHailey 1.5/30ATC—REGISTER NO.US:68462-504_299fb286…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
Manufacturer
Glenmark Pharmaceuticals Inc., USA
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
    6846250481
    3 POUCH in 1 CARTON (68462-504-81) / 1 BLISTER PACK in 1 POUCH (68462-504-79) / 21 TABLET in 1 BLISTER PACK
  • ndc11
    68462-504-81

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/4d58616c-dab4-4c6a-b851-92b50e5c8b0d
GET /v1/drugs/4d58616c-dab4-4c6a-b851-92b50e5c8b0d?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": "1.5; .03",
  "substance": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
  "productndc": "68462-504",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA209297",
  "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.