United States· US:0406-9914_300ed63a-6bbc-4dbd-ba1d-e4eda4737e09
RESTORIL
A medicinal product containing temazepam, registered in United States by SpecGx 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
- temazepam
- Manufacturer
- SpecGx 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 12, 2026
Packs & prices · 1
- ndc11040699140330 CAPSULE in 1 BOTTLE (0406-9914-03)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Temazepam in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomTemazepam 10mg tabletsNational Generics
- FinlandNormisonMeda Oy
- NetherlandsTemazepam Auro 10 mg, tablettenAurobindo Pharma B.V.
- SwitzerlandNormison 20 mg, WeichkapselnViatris Pharma GmbH
- GermanyRemestanViatris Healthcare Gmbh
- IrelandNortem 10mg TabletsTeva B.V.
- CanadaRESTORILAA PHARMA INC
- PolandSignopamTarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
Authorised across Europe · EMA
The same active substance is authorised in 9 EEA countries. Names it is sold under:
- Germany · Remestan, Remestan Mite
- Finland · Tenox
- United Kingdom (Northern Ireland) · Temazepam, Temazepam Generics [uk]
- Hungary · Signopam
- Ireland · Nortem
- Malta · Temazepam Thame
- Netherlands · Temazepam Auro, Temazepam Aurobindo
- Poland · Signopam, Teseda
- Portugal · Normison
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/8923f42e-4b43-46c3-8442-665f43a6cfa4 GET /v1/drugs/8923f42e-4b43-46c3-8442-665f43a6cfa4?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",
"livertox": {
"summary": null,
"livertox_id": null,
"hepatotoxicity_score": 5
},
"productid": "0406-9914_300ed63a-6bbc-4dbd-ba1d-e4eda4737e09",
"productndc": "0406-9914",
"dosage_form": "CAPSULE",
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TEMAZEPAM",
"proprietary_name": "RESTORIL",
"active_ingred_unit": "mg/1",
"application_number": "NDA018163",
"marketing_category": "NDA",
"nonproprietary_name": "temazepam",
"start_marketing_date": "19810227",
"active_numerator_strength": "22.5"
}See everything about temazepam.
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.