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Medicine

Dexamethasone 10 mg/1 mL injection

Dexamethasone · Intramuscular, intravenous
Available on requestPrescription onlyUS FDAGeneric name

Dexamethasone 10 mg/1 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 14 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).

Key facts

Active ingredient (INN)
Dexamethasone
Brand
Sold under the generic name
Strength
10 mg/1 mL
Dosage form
Injection
Route
Intramuscular, intravenous
Packs
25 vials of 1 mL, 1 vial of 1 mL, 1 mL and 16 more
Manufacturers
Micro LabsIndiaEugiaIndiaFresenius KabiSportpharmA-S Medication SolutionsAdvanced Rx Pharmacy of TennesseeAmneal PharmaceuticalsArmas PharmaceuticalsCardinal HealthHealthFirst
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A01AC02 Dexamethasone
HS code (indicative)
3004.32Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
7 September 1982
Identifiers
RxCUI 1812079, 309696, 1116927 +1DailyMed set ID 29947f67-7868-40af-8ad2-a61f7149b44c, f4d6c7c8-7a77-6a46-e053-2995a90a4411, 7da9da65-0c03-23e2-e053-2a91aa0a042f +13NDC 55150-304, 80425-0261, 51662-1343 +12Application ANDA210966, ANDA207442, ANDA087702 +3

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 in 1 carton / 1 mL in 1 vial55150-304-25EugiaIndia5 June 2020
1 vial in 1 carton / 1 mL in 1 vial42571-432-40Micro LabsIndia1 August 2026
25 vial in 1 carton / 1 mL in 1 vial42571-432-79Micro LabsIndia1 June 2024
25 vial in 1 tray / 1 mL in 1 vial63323-506-01Fresenius Kabi29 May 2003
25 vial in 1 tray / 1 mL in 1 vial63323-506-13Fresenius Kabi6 January 2025
25 vial in 1 tray / 1 mL in 1 vial63323-506-16Fresenius Kabi29 May 2003
25 vial in 1 carton / 1 mL in 1 vial70121-1399-5Amneal Pharmaceuticals26 August 2018
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose72485-118-25Armas Pharmaceuticals22 April 2025
25 vial in 1 carton / 1 mL in 1 vial0641-0367-25Hikma Pharmaceuticals7 September 1982
25 vial in 1 carton / 1 mL in 1 vial70069-021-25Somerset Therapeutics19 April 2018
1 mL in 1 vial85766-071-01Sportpharm1 October 2025
25 vial in 1 tray / 1 mL in 1 vial85766-071-25Sportpharm1 October 2025
25 vial in 1 tray / 1 mL in 1 vial85766-186-25Sportpharm20 March 2026
25 vial in 1 carton / 1 mL in 1 vial50090-3541-0A-S Medication Solutions16 August 2018
25 vial in 1 carton / 1 mL in 1 vial80425-0261-1Advanced Rx Pharmacy of Tennessee16 February 2023
5 vial in 1 bag / 1 mL in 1 vial55154-5118-5Cardinal Health7 September 1982
25 pouch in 1 case / 1 vial in 1 pouch / 1 mL in 1 vial51662-1343-3HealthFirst22 December 2018
1 vial in 1 bag / 1 mL in 1 vial71872-7091-1Medical Purchasing Solutions30 March 2018
25 vial in 1 carton / 1 mL in 1 vial70518-0532-1Remedyrepack17 May 2017
25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose68083-607-25—25 September 2023
25 vial in 1 carton / 1 mL in 1 vial25021-053-01—1 December 2024

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 30 October 1958Drugs@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

Alternatives

Other makers and brands of Dexamethasone 10 mg/1 mL injection.

Compare 1

Other strengths and forms of Dexamethasone

Clinical summary

Dexamethasone is a corticosteroid. It is available as tablets, injection and elixir for oral, intramuscular and intravenous use. MedsAcross supplies Dexamethasone 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 Dexamethasone

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

Data sources

Need Dexamethasone 10 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.