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Medicine

Midazolam 2 mg/2 mL injection

Midazolam · Intramuscular, intravenous
Available on requestPrescription onlyUS FDAControlled, schedule CIVGeneric name

Midazolam 2 mg/2 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 12 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

Available on request

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), excursions permitted to 15° to 30°C (59°…

Key facts

Active ingredient (INN)
Midazolam
Brand
Sold under the generic name
Strength
2 mg/2 mL
Dosage form
Injection
Route
Intramuscular, intravenous
Packs
25 vials of 2 mL, 10 vials of 2 mL, 10 syringes of 2 mL and 18 more
Manufacturers
Avet PharmaceuticalsIndiaGland PharmaIndiaMicro LabsIndiaHikma PharmaceuticalsFresenius KabiHospiraSomerset TherapeuticsCardinal HealthCivicaOnesource Specialty Pharma
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
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 311700, 311702, 1666798 +6DailyMed set ID 8675cdb1-c7f5-40cf-b1e0-0960b7ab117b, f8bb3427-c887-47b6-8042-8a21dc161c79, e22611dd-1830-40af-9139-7cdb07f5a426 +13NDC 0641-6209, 0641-6281, 25021-655 +15Application ANDA075243, ANDA090696, ANDA203460 +5

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.

PackCodeLabelerMarketed since
25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose23155-600-41Avet PharmaceuticalsIndia8 November 2016
10 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose68083-106-01Gland PharmaIndia1 June 2012
25 vial in 1 carton / 2 mL in 1 vial42571-414-87Micro LabsIndia1 January 2024
10 vial in 1 carton / 2 mL in 1 vial0641-6057-10Hikma Pharmaceuticals20 June 2000
25 vial in 1 carton / 2 mL in 1 vial0641-6057-25Hikma Pharmaceuticals20 June 2000
25 vial in 1 carton / 2 mL in 1 vial0641-6209-25Hikma Pharmaceuticals20 June 2000
10 syringe in 1 carton / 2 mL in 1 syringe0641-6220-10Hikma Pharmaceuticals29 March 2024
25 vial in 1 carton / 2 mL in 1 vial0641-6281-25Hikma Pharmaceuticals20 June 2000
25 vial in 1 tray / 2 mL in 1 vial63323-411-12Fresenius Kabi14 July 2000
25 vial in 1 tray / 2 mL in 1 vial63323-411-27Fresenius Kabi6 January 2025
24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 2 mL in 1 syringe, glass76045-001-20Fresenius Kabi3 October 2014
24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 2 mL in 1 syringe, glass76045-211-20Fresenius Kabi16 April 2021
25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose0409-0001-25Hospira27 January 2025
25 vial, single-dose in 1 tray / 2 mL in 1 vial, single-dose0409-2305-17Hospira29 June 2010
10 vial in 1 carton / 2 mL in 1 vial83270-170-10Onesource Specialty Pharma27 February 2026
10 vial in 1 carton / 2 mL in 1 vial25021-655-02Sagent Pharmaceuticals19 March 2012
10 vial in 1 carton / 2 mL in 1 vial70069-816-10Somerset Therapeutics5 December 2023
25 vial in 1 carton / 2 mL in 1 vial70069-816-25Somerset Therapeutics5 December 2023
5 vial, single-dose in 1 bag / 2 mL in 1 vial, single-dose55154-4743-5Cardinal Health22 July 2002
25 vial in 1 carton / 2 mL in 1 vial72572-430-25Civica10 December 2019
10 vial in 1 carton / 2 mL in 1 vial70518-4328-0Remedyrepack14 April 2025

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 20 December 1985Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

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 Midazolam

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Midazolam 2 mg/2 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.