Medicine
Midazolam 5 mg/1 mL injection
Midazolam 5 mg/1 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 6 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F) Do not place syringe on a sterile field.
Key facts
- Active ingredient (INN)
- Midazolam
- Brand
- Sold under the generic name
- Strength
- 5 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 10 vials of 1 mL, 25 vials of 1 mL, 24 blister pack of 1 mL and 7 more
- Manufacturers
- Micro LabsIndiaHikma PharmaceuticalsFresenius KabiHospiraHenry ScheinOnesource Specialty Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F) Do not place syringe on a sterile field.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- ATC code
- N05CD08 Midazolam
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 June 2000
- Identifiers
- RxCUI 998211, 1551393, 1551395 +6DailyMed set ID 1cc9ba6e-fa1b-405e-9de8-720c567b2a73, 575d8bf0-7af7-427c-a231-966e2a5e070d, 9221894f-d840-46f2-a11c-6b71358d3b5b +6NDC 76045-002, 0641-6061, 42571-415 +5Application ANDA203460, ANDA075243, ANDA217504 +4
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 vial in 1 carton / 1 mL in 1 vial | 42571-415-72 | Micro LabsIndia | 1 January 2024 |
| 25 vial in 1 tray / 1 mL in 1 vial | 63323-412-25 | Fresenius Kabi | 10 July 2000 |
| 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass | 76045-002-10 | Fresenius Kabi | 3 October 2014 |
| 10 vial in 1 carton / 1 mL in 1 vial | 0641-6061-10 | Hikma Pharmaceuticals | 20 June 2000 |
| 25 vial in 1 carton / 1 mL in 1 vial | 0641-6061-25 | Hikma Pharmaceuticals | 20 June 2000 |
| 10 syringe in 1 carton / 1 mL in 1 syringe | 0641-6218-10 | Hikma Pharmaceuticals | 29 March 2024 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 0409-2308-01 | Hospira | 14 June 2005 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 0409-2308-49 | Hospira | 28 December 2005 |
| 10 vial in 1 carton / 1 mL in 1 vial | 83270-172-10 | Onesource Specialty Pharma | 27 February 2026 |
| 1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 0404-9916-01 | Henry Schein | 17 January 2022 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Midazolam
Clinical summary
Midazolam is a benzodiazepine indicated for the acute treatment of intermittent, among other approved uses. It is available as injection, syrup and nasal spray for intravenous, intramuscular and oral use. MedsAcross supplies Midazolam for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MidazolamFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nayzilam prescribing information (UCB) · U.S. National Library of Medicine, DailyMed
- Buccolam: European public assessment report (EPAR) · European Medicines Agency
Need Midazolam 5 mg/1 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.