United States· US:0121-0945_e4cbdf23-39ea-4f8e-b7b3-139b45d169f6
Megestrol Acetate
A medicinal product containing megestrol acetate, registered in United States by PAI Holdings, LLC dba PAI Pharma.
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
- MEGESTROL ACETATE
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- 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 · 4
- ndc11012109450010 TRAY in 1 CASE (0121-0945-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0945-10)
- ndc1101210945404 TRAY in 1 CASE (0121-0945-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0945-10)
- ndc110121-0945-00
- ndc110121-0945-40
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Megestrol acetate in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- IrelandMegace 40 mg/ml oral suspensionPCO Manufacturing Ltd.
- PolandCachexanPolfarmex S.A.
- SpainMAYGACE ALTAS DOSIS 40 mg/ml SUSPENSION ORALBausch Health Ireland Limited
- CzechiaMEGACEBausch Health Ireland Limited, Dublin
- United KingdomMegace 160mg tabletsDowelhurst Ltd
- ItalyGESTROLTEXISTITUTO GENTILI S.R.L.
- FinlandMegaceBristol-Myers Squibb Ab
- CanadaMEGESTROLAA PHARMA INC
Authorised across Europe · EMA
The same active substance is authorised in 22 EEA countries. Names it is sold under:
- Belgium · Megace
- Cyprus · Megace
- Czechia · Megace, Megaplex
- Germany · Megestat
- Spain · Borea, Maygace Altas Dosis
- France · Megace
- United Kingdom (Northern Ireland) · Megace
- Greece · Megace
- Croatia · Megace, Megostat
- Hungary · Cachexi, Megace
- Ireland · Megace
- Italy · Gestroltex, Megace
- Lithuania · Megace
- Luxembourg · Megace
- Netherlands · Megestrolacetaat Focus
- Norway · Megace
- Poland · Cachexan, Megace
- Portugal · Megace, Megestrol Generis
- Romania · Megesin
- Sweden · Megace
- Slovenia · Megace
- Slovakia · Megesin
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/79f9148a-0e62-4ff2-8728-4d37dd99a3b1 GET /v1/drugs/79f9148a-0e62-4ff2-8728-4d37dd99a3b1?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": "400",
"substance": "MEGESTROL ACETATE",
"productndc": "0121-0945",
"dosage_form": "SUSPENSION",
"dea_schedule": null,
"strength_unit": "mg/10mL",
"application_number": "ANDA075671",
"marketing_category": "ANDA"
}See everything about megestrol 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.