United States· US:72495-401_2b9876fb-e9e0-4dbc-e063-6294a90a8696
Intrarosa
A medicinal product containing prasterone, registered in United States by Millicent US, Inc..
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
- PRASTERONE
- Manufacturer
- Millicent US, Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- July 12, 2026
Packs & prices · 2
- ndc1172495401281 BOX in 1 BOX (72495-401-28) / 28 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK
- ndc1172495-401-28
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Prasterone in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- Norway7-keto DHEA pure encapsPure encapsulations
- PolandBiosteronPrzedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
- United KingdomDHEA 10mg tabletsImported (United States)
- SwitzerlandIntrarosa 6.5 mg, OvuleLabatec Pharma SA
- FinlandIntrarosaEndoceutics S.A.
- CzechiaINTRAROSAEndoceutics S.A., Brusel
- IrelandIntrarosa 6.5 mg pessaryEndoceutics S.A.
- IcelandIntrarosaEndoceutics*
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- Iceland · Intrarosa
- Liechtenstein · Intrarosa
- Norway · Intrarosa
- Poland · Biosteron, Dhea
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/71c8b095-da1b-4fa9-af98-c538f350cc08 GET /v1/drugs/71c8b095-da1b-4fa9-af98-c538f350cc08?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": "VAGINAL",
"source": "ndc",
"strength": "6.5",
"substance": "PRASTERONE",
"productndc": "72495-401",
"dosage_form": "INSERT",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA208470",
"marketing_category": "NDA"
}See everything about prasterone.
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.