United States· US:76045-003_ec9c9aee-b95f-4645-bf17-df7f1e3967d3
Midazolam
A medicinal product containing midazolam hydrochloride, registered in United States by Fresenius Kabi USA, 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
- MIDAZOLAM HYDROCHLORIDE
- Manufacturer
- Fresenius Kabi USA, 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 27, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Midazolam hydrochloride in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- IrelandHypnovel 10 mg/2 ml Solution for InjectionCHEPLAPHARM Arzneimittel GmbH
- United KingdomBuccolam 10mg/2ml oromucosal solution pre-filled oral syringesMawdsley-Brooks & Company Ltd
- CzechiaBUCCOLAMNeuraxpharm Pharmaceuticals, S.L., Barcelona
- NetherlandsBuccolam 10mg/2ml, oplossing voor oromucosaal gebruikLaboratorios Lesvi S.L.
- FinlandBUCCOLAMNeuraxpharm Pharmaceuticals S.L.
- BelgiumBuccolam 10 mgNeuraxpharm Pharmaceuticals
- GermanyDormicumCheplapharm Arzneimittel Gmbh
- PolandBuccolamNeuraxpharm Pharmaceuticals, S.L.
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/ea0714b6-1256-43e2-922a-1cf7fd0cf6a5 GET /v1/drugs/ea0714b6-1256-43e2-922a-1cf7fd0cf6a5?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": "INTRAMUSCULAR; INTRAVENOUS",
"source": "ndc",
"strength": "10",
"substance": "MIDAZOLAM HYDROCHLORIDE",
"productndc": "76045-003",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": "CIV",
"strength_unit": "mg/2mL",
"application_number": "ANDA203460",
"marketing_category": "ANDA"
}See everything about midazolam hydrochloride.
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.