United States· US:82449-206_0c63b5cb-696a-9c6c-e063-6394a90a8fd9

Midazolam

A midazolam product containing midazolam hydrochloride, registered in United States by Steriscience Specialties Private Limited. The same ATC class is registered in 14 of our 19 countries.

In shortageATC N05CD08Orange BookUS 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…normalisedMidazolamATCN05CD08REGISTER NO.US:82449-206_0c63b5cb…PACKS LISTED1CHECKEDSeptember 12, 2026

Where it is registered

Midazolam is registered in 14 of 19 countries.

Countries holding a registration under ATC N05CD08 (midazolam), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 9 of them publish a price we can compare per daily dose

Midazolam · ATC N05CD08

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • 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 midazolam costs, country by country.

Normalised to the WHO defined daily dose (5 mg), the median price runs from $0.55 in Switzerland to $4.74 in Finland — a ×8.6 gap.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Midazolam · price per daily dose (5 mg)

USD · FX 28 Sept 2026

  • FI Finland$4.74
  • CH Switzerland$0.55
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
midazolam hydrochloride
Manufacturer
Steriscience Specialties Private Limited
Country
United States (US)
ATC code
N05CD08
ATC class
Midazolam
Defined daily dose
5 mg, N
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    8244920602
    10 VIAL in 1 CARTON (82449-206-02) / 2 mL in 1 VIAL

Regulatory notes

UNII (FDA substance ID)
W7TTW573JJ
MIDAZOLAM HYDROCHLORIDE
RxCUI 203128
Orange Book
A090315
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Midazolam Hydrochloride Injection

Interactions

316 interactions on record for midazolam.

Graded by severity as the source publishes them — 9 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

Midazolam · interactions on record

316 records

  • 9 severe
  • 156 moderate
  • 34 minor
  • 57 info

Most severe, free to view

  • KetoconazoleH02CA03severe
  • KetoconazoleJ02AB02severe
  • FluconazoleJ02AC01severe
  • Darunavir and cobicistatJ05AR14severe

60 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

Midazolam in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All midazolam products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

  • Austria · Dormicum, Epistatus
  • Belgium · Midazolam Accord Healthcare, Midazolam Aguettant
  • Bulgaria · Midazolam Kalceks, Мидазолам Хамелн
  • Cyprus · Midazolam Accord, Midazolam B. Braun
  • Czechia · Dormicum, Midazolam Accord
  • Germany · Dormicum, Dormicum V
  • Denmark · Epistatus, Midazolam "hameln"
  • Estonia · Midazolam Kalceks
  • Spain · Dormicum, Midazolam Accord
  • Finland · Dormicum, Epistatus
  • France · Hypnovel, Midazolam Accord
  • United Kingdom (Northern Ireland) · Hypnovel, Midazolam Accord Healthcare
  • Greece · Dormicum, Dormipnol
  • Croatia · Dormicum, Midazolam B. Braun
  • Hungary · Dormicum, Epistatus
  • Ireland · Epistatus, Hypnovel
  • Iceland · Buccolam, Midazolam Accord
  • Italy · Epistatus, Midazolam Accord Healthcare
  • Liechtenstein · Buccolam
  • Lithuania · Fulsed, Midazolam B. Braun
  • Luxembourg · Midazolam Aguettant, Midazolam B. Braun
  • Latvia · Fulsed, Midazolam B. Braun
  • Malta · Midazolam Bp Accord Healthcare, Miprosed
  • Netherlands · Dormicum, Midazolam Accord
  • Norway · Buccolam, Epistatus
  • Poland · Dormicum, Epistatus
  • Portugal · Dormicum, Midazolam Accord
  • Romania · Midazolam Desitin, Midazolam Hameln
  • Sweden · Epistatus, Midazolam Accord
  • Slovenia · Dormicum, Epistatus
  • Slovakia · Midazolam Accord, Midazolam Hameln

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/d93b6b93-5c05-4bb9-b1c1-977c42307f21
GET /v1/drugs/d93b6b93-5c05-4bb9-b1c1-977c42307f21?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.

{
  "unii": {
    "unii": "W7TTW573JJ",
    "rxcui": "203128",
    "inchikey": "PLYSCVSCYOQVRP-UHFFFAOYSA-N",
    "display_name": "MIDAZOLAM HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "8b690f5c-2923-4c34-a8f7-11af5f546b62": {
      "match": "brand_token",
      "title": "MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
      "spl_version": "13",
      "published_date": "2026-05-28"
    }
  },
  "productid": "82449-206_0c63b5cb-696a-9c6c-e063-6394a90a8fd9",
  "productndc": "82449-206",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "090315",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "Nov 29, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/ML",
        "product_no": "002",
        "approval_date": "Nov 29, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIDAZOLAM HYDROCHLORIDE",
  "shortage_reason": "Midazolam Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Midazolam",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090315",
  "marketing_category": "ANDA",
  "nonproprietary_name": "midazolam hydrochloride",
  "start_marketing_date": "20230731",
  "active_numerator_strength": "5"
}

See everything about midazolam.

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.