United States· US:0641-6209_6a9280fb-c775-443b-9f8e-1ed3a0c85d13
Midazolam
A medicinal product containing midazolam hydrochloride, registered in United States by Hikma Pharmaceuticals USA Inc..
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
- Hikma Pharmaceuticals USA Inc.
- 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 · 2
- ndc11064162092525 VIAL in 1 CARTON (0641-6209-25) / 2 mL in 1 VIAL (0641-6209-01)
- ndc110641-6209-25
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.
- 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.
- SwedenBUCCOLAM 10 mg MunhålelösningNeuraxpharm 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/ec39915f-9639-4faf-8d2c-79a3d935f0ef GET /v1/drugs/ec39915f-9639-4faf-8d2c-79a3d935f0ef?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": "1",
"substance": "MIDAZOLAM HYDROCHLORIDE",
"productndc": "0641-6209",
"dosage_form": "INJECTION",
"dea_schedule": "CIV",
"strength_unit": "mg/mL",
"application_number": "ANDA075243",
"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.