United States· US:43353-260_ec1b0a54-5f93-45ed-bbbf-0bf3cd42ba73

temazepam

A temazepam product containing temazepam, registered in United States by Aphena Pharma Solutions - Tennessee, LLC. The same ATC class is registered in 9 of our 19 countries.

ATC N05CD07US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedtemazepamATCN05CD07REGISTER NO.US:43353-260_ec1b0a54…PACKS LISTED12CHECKEDSeptember 27, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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)
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
TEMAZEPAM
Manufacturer
Aphena Pharma Solutions - Tennessee, 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 · 12

  • ndc11
    43353-260-20
  • ndc11
    43353-260-28
  • ndc11
    43353-260-30
  • ndc11
    43353-260-53
  • ndc11
    43353-260-60
  • ndc11
    4335326015
    15 CAPSULE in 1 BOTTLE (43353-260-15)
  • ndc11
    4335326020
    20 CAPSULE in 1 BOTTLE (43353-260-20)
  • ndc11
    4335326028
    28 CAPSULE in 1 BOTTLE (43353-260-28)
  • ndc11
    4335326030
    30 CAPSULE in 1 BOTTLE (43353-260-30)
  • ndc11
    4335326053
    60 CAPSULE in 1 BOTTLE (43353-260-53)
  • ndc11
    4335326060
    90 CAPSULE in 1 BOTTLE (43353-260-60)
  • ndc11
    43353-260-15

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All temazepam products

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/e837a55b-82ca-4c7f-ae4d-74a956e0ae14
GET /v1/drugs/e837a55b-82ca-4c7f-ae4d-74a956e0ae14?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": "30",
  "substance": "TEMAZEPAM",
  "productndc": "43353-260",
  "dosage_form": "CAPSULE",
  "dea_schedule": "CIV",
  "strength_unit": "mg/1",
  "application_number": "ANDA071457",
  "marketing_category": "ANDA"
}

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.