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Medicine

Hydrocortisone 5 mg tablet

Available on requestPrescription onlyUS FDAGeneric name

Hydrocortisone 5 mg tablet is a generic prescription medicine for oral 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 controlled room temperature 20° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Hydrocortisone
Brand
Sold under the generic name
Strength
5 mg
Dosage form
Tablet
Route
Oral
Packs
50 tablets, 60 tablets, 30 tablets and 29 more
Manufacturers
Strides PharmaIndiaAurobindo PharmaIndiaBryant Ranch PrepackAsclemedPreferred PharmaceuticalsAmerican Health PackagingAmneal Pharmaceuticals of New YorkANI PharmaceuticalsAvPAKChartwell RX
Origin register
US FDA, United States
Storage
Store at controlled room temperature 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
A01AC03 Hydrocortisone
HS code (indicative)
3004.32Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
30 March 2007
Identifiers
RxCUI 197782, 197783, 197787DailyMed set ID bc751403-94f2-4f9d-b533-cf6186a40ceb, 305f2042-5bc6-4abd-a3bb-e5c0961c04dd, c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6 +15NDC 59762-0073, 72162-2685, 42543-970 +15Application NDA008697, ANDA207029, ANDA040646 +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.

PackCodeLabelerMarketed since
50 tablet in 1 bottle, plastic42543-970-25Strides PharmaIndia22 December 2021
50 tablet in 1 bottle, plastic64380-970-25Strides PharmaIndia25 September 2020
50 tablet in 1 bottle59651-413-50Aurobindo PharmaIndia17 July 2023
50 tablet in 1 bottle, plastic0115-1696-06Amneal Pharmaceuticals of New York30 March 2007
50 tablet in 1 bottle70954-052-10ANI Pharmaceuticals5 May 2025
60 tablet in 1 bottle62135-551-60Chartwell RX13 March 2023
50 tablet in 1 bottle71930-078-50Eywa Pharma7 October 2022
50 tablet in 1 bottle59762-0073-1Mylan Pharmaceuticals20 February 2013
50 tablet in 1 bottle43547-892-05Solco Healthcare17 August 2026
30 tablet in 1 bottle, plastic71335-1989-1Bryant Ranch Prepack18 July 2024
90 tablet in 1 bottle, plastic71335-1989-2Bryant Ranch Prepack18 July 2024
58 tablet in 1 bottle, plastic71335-1989-3Bryant Ranch Prepack18 July 2024
28 tablet in 1 bottle, plastic71335-1989-4Bryant Ranch Prepack18 July 2024
60 tablet in 1 bottle, plastic71335-1989-5Bryant Ranch Prepack11 November 2021
100 tablet in 1 bottle, plastic71335-1989-6Bryant Ranch Prepack18 July 2024
30 tablet in 1 bottle71335-2770-1Bryant Ranch Prepack3 October 2025
90 tablet in 1 bottle71335-2770-2Bryant Ranch Prepack3 October 2025
58 tablet in 1 bottle71335-2770-3Bryant Ranch Prepack3 October 2025
28 tablet in 1 bottle71335-2770-4Bryant Ranch Prepack3 October 2025
60 tablet in 1 bottle71335-2770-5Bryant Ranch Prepack3 October 2025
100 tablet in 1 bottle71335-2770-6Bryant Ranch Prepack3 October 2025
100 tablet in 1 bottle, plastic72162-2685-1Bryant Ranch Prepack29 October 2026
50 tablet in 1 bottle, plastic72162-2685-2Bryant Ranch Prepack29 October 2026
50 tablet in 1 bottle76420-028-50Asclemed24 December 2019
90 tablet in 1 bottle76420-028-90Asclemed24 December 2019
50 tablet in 1 bottle, plastic76420-110-50Asclemed10 April 2021
30 blister pack in 1 carton / 1 tablet in 1 blister pack60687-844-21American Health Packaging18 June 2025
50 blister pack in 1 box / 1 tablet in 1 blister pack50268-405-15AvPAK31 January 2023
50 tablet in 1 bottle, plastic72789-227-50PD-Rx Pharmaceuticals22 December 2022
30 tablet in 1 bottle, plastic68788-8455-3Preferred Pharmaceuticals5 June 2023
60 tablet in 1 bottle, plastic68788-8455-6Preferred Pharmaceuticals5 June 2023
90 tablet in 1 bottle, plastic68788-8455-9Preferred Pharmaceuticals5 June 2023

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 21 December 1951Drugs@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 Hydrocortisone 5 mg tablet.

Compare 1

Other strengths and forms of Hydrocortisone

Clinical summary

Hydrocortisone is a corticosteroid indicated in conditions. It is available as cream, tablets and ointment for topical, oral and intramuscular use. MedsAcross supplies Hydrocortisone 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 Hydrocortisone

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

Data sources

Need Hydrocortisone 5 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.