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MedsAcross

Medicine

Dexamethasone 0.75 mg tablet

Available on requestPrescription onlyUS FDAGeneric name

Dexamethasone 0.75 mg tablet is a generic prescription medicine for oral use, made by 10 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

Do not freeze. Store and Dispense Store at 20° to 25°C (68° to 77°F). NDC…

Key facts

Active ingredient (INN)
Dexamethasone
Brand
Sold under the generic name
Strength
0.75 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 100 blister pack, 10 tablets and 30 more
Manufacturers
Viona PharmaceuticalsIndiaZydus LifesciencesIndiaBryant Ranch PrepackPreferred PharmaceuticalsPD-Rx PharmaceuticalsHikma PharmaceuticalsAdvagen PharmaANI PharmaceuticalsApotexDirect_Rx
Origin register
US FDA, United States
Storage
Do not freeze. Store and Dispense Store at 20° to 25°C (68° to 77°F). NDC 0054-3177-57: Bottle of 240 mL NDC 0054-3177-63: Bottle of 500 mL Store and Dispense 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
3 June 1975
Identifiers
RxCUI 343033, 197577, 197579 +6DailyMed set ID e90cb7f5-5e99-fbf3-e053-2995a90a70aa, 736861fa-1df8-4afd-ba4a-dd7d7bffd865, 710ce0fc-78b3-402d-a2ca-e5eda09f3211 +11NDC 72189-383, 55289-903, 71335-2405 +12Application ANDA084613, ANDA215604, ANDA217695 +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
100 tablet in 1 bottle72578-169-01Viona PharmaceuticalsIndia15 April 2024
100 tablet in 1 bottle70771-1705-1Zydus LifesciencesIndia15 April 2024
100 tablet in 1 bottle, plastic0054-4180-25Hikma Pharmaceuticals3 June 1975
100 blister pack in 1 carton / 1 tablet in 1 blister pack0054-8180-25Hikma Pharmaceuticals3 June 1975
100 tablet in 1 bottle72888-236-01Advagen Pharma15 October 2025
100 tablet in 1 bottle70954-399-10ANI Pharmaceuticals9 October 2023
100 tablet in 1 bottle60505-6250-1Apotex5 December 2023
10 tablet in 1 bottle, plastic55289-903-10PD-Rx Pharmaceuticals31 August 2009
12 tablet in 1 bottle, plastic55289-903-12PD-Rx Pharmaceuticals31 August 2009
20 tablet in 1 bottle, plastic55289-903-20PD-Rx Pharmaceuticals31 August 2009
20 tablet in 1 bottle, plastic72789-501-20PD-Rx Pharmaceuticals30 April 2025
12 tablet in 1 bottle, plastic72789-599-12PD-Rx Pharmaceuticals20 October 2026
12 tablet in 1 bottle63629-4129-1Bryant Ranch Prepack8 February 2010
42 tablet in 1 bottle63629-4129-2Bryant Ranch Prepack8 February 2010
30 tablet in 1 bottle63629-4129-3Bryant Ranch Prepack8 February 2010
21 tablet in 1 bottle63629-4129-4Bryant Ranch Prepack8 February 2010
20 tablet in 1 bottle63629-4129-5Bryant Ranch Prepack8 February 2010
90 tablet in 1 bottle63629-4129-6Bryant Ranch Prepack8 February 2010
12 tablet in 1 bottle71335-2405-1Bryant Ranch Prepack11 June 2024
42 tablet in 1 bottle71335-2405-2Bryant Ranch Prepack11 June 2024
30 tablet in 1 bottle71335-2405-3Bryant Ranch Prepack11 June 2024
21 tablet in 1 bottle71335-2405-4Bryant Ranch Prepack11 June 2024
20 tablet in 1 bottle71335-2405-5Bryant Ranch Prepack11 June 2024
90 tablet in 1 bottle71335-2405-6Bryant Ranch Prepack11 June 2024
100 tablet in 1 bottle, plastic68788-7267-0Preferred Pharmaceuticals25 September 2018
12 tablet in 1 bottle, plastic68788-7267-1Preferred Pharmaceuticals25 September 2018
21 tablet in 1 bottle, plastic68788-7267-2Preferred Pharmaceuticals25 September 2018
30 tablet in 1 bottle, plastic68788-7267-3Preferred Pharmaceuticals25 September 2018
100 tablet in 1 bottle68788-8763-0Preferred Pharmaceuticals11 November 2024
12 tablet in 1 bottle68788-8763-1Preferred Pharmaceuticals11 November 2024
21 tablet in 1 bottle68788-8763-2Preferred Pharmaceuticals11 November 2024
30 tablet in 1 bottle68788-8763-3Preferred Pharmaceuticals11 November 2024
30 tablet in 1 bottle72189-383-30Direct_Rx19 September 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.

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

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 0.75 mg tablet 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.