United States· US:65162-475_764f6075-288a-4435-b148-35589e5e5835
Norethindrone Acetate
A medicinal product containing norethindrone acetate, registered in United States by Amneal Pharmaceuticals LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- NORETHINDRONE ACETATE
- Manufacturer
- Amneal Pharmaceuticals LLC
- 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 · 8
- ndc1165162-475-03
- ndc1165162-475-05
- ndc1165162-475-09
- ndc1165162-475-50
- ndc11651624750330 TABLET in 1 BOTTLE (65162-475-03)
- ndc11651624750550 TABLET in 1 BOTTLE (65162-475-05)
- ndc11651624750990 TABLET in 1 BOTTLE (65162-475-09)
- ndc116516247550500 TABLET in 1 BOTTLE (65162-475-50)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Norethindrone acetate in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomNorethisterone 5mg tabletsSigma Pharmaceuticals Plc
- PolandPrimolut-NorMedezin Sp. z o.o.
- FinlandPrimolut NParanova Oy
- CzechiaNORETHISTERON ZENTIVAZentiva a.s., Bratislava
- NorwayPrimolut NBayer AB - Solna
- SwedenPrimolut-Nor 5 mg TablettBayer AB
- IcelandPrimolut NBayer AB*
- SwitzerlandPrimolut N, TablettenBayer (Schweiz) AG
Authorised across Europe · EMA
The same active substance is authorised in 18 EEA countries. Names it is sold under:
- Bulgaria · Примолут-Нор
- Cyprus · Norethisterone Remedica
- Czechia · Norethisteron Zentiva
- Denmark · Mini-Pe
- Spain · Primolut-Nor
- Finland · Mini-Pill, Primolut N
- United Kingdom (Northern Ireland) · Norethisterone Noumed Life Sciences, Norethisterone Wockhardt Uk
- Hungary · Norcolut
- Ireland · Noriday
- Iceland · Primolut N
- Italy · Primolut Nor
- Malta · Norethisterone Remedica
- Netherlands · Primolut N
- Norway · Conludag, Primolut N
- Poland · Primolut-Nor
- Sweden · Mini-Pe, Primolut-Nor
- Slovenia · Primolut Nor
- Slovakia · Norethisteron Zentiva
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/b8728e0c-30f9-40e4-8445-13cea0fa3dff GET /v1/drugs/b8728e0c-30f9-40e4-8445-13cea0fa3dff?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": "5",
"substance": "NORETHINDRONE ACETATE",
"productndc": "65162-475",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA200275",
"marketing_category": "ANDA"
}See everything about 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.