United States· US:0406-9915_f0ee4fa9-cdff-4111-83a5-0885c81de4e4
RESTORIL
A temazepam product containing temazepam, registered in United States by SpecGx LLC. The same ATC class is registered in 9 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Temazepam is registered in 9 of 19 countries.
Countries holding a registration under ATC N05CD07 (temazepam), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 4 of them publish a price we can compare per daily dose
Temazepam · ATC N05CD07
9 / 19 countries
- Canada
- Finlandprice
- Germany
- Ireland
- Netherlands
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of temazepam costs, country by country.
Normalised to the WHO defined daily dose (20 mg), so markets compare like for like.
- United States: $0.74 per daily dose (median across products in the class)
- Public list prices, converted to USD at the rate date shown
- US figures are pharmacy acquisition cost (CMS NADAC), not retail
Temazepam · price per daily dose (20 mg)
USD · FX 28 Sept 2026
- CH Switzerland$0.79
- US United States$0.74 (acquisition cost)
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- TEMAZEPAM
- Manufacturer
- SpecGx LLC
- Country
- United States (US)
- ATC code
- N05CD07
- ATC class
- Temazepam
- Defined daily dose
- 20 mg, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc110406-9915-01
- ndc110406-9915-03
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
319 interactions on record for temazepam.
Graded by severity as the source publishes them — 4 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Temazepam · interactions on record
319 records
- 4 severe
- 72 moderate
- 22 minor
- 218 info
Most severe, free to view
- MorphineN02AA01severe
- MorphinN07BC09severe
- HydrocodoneR05DA03severe
- CodeineR05DA04severe
3 more interactions with mechanism and management, from a commercially licensed source.
Sign in to check- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
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/8b594439-2154-4463-87ce-bdb89bc535af GET /v1/drugs/8b594439-2154-4463-87ce-bdb89bc535af?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": "7.5",
"substance": "TEMAZEPAM",
"productndc": "0406-9915",
"dosage_form": "CAPSULE",
"dea_schedule": "CIV",
"strength_unit": "mg/1",
"application_number": "NDA018163",
"marketing_category": "NDA"
}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.