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MedsAcross

Medicine

Hydrocortisone 2.5% ointment

Hydrocortisone · Topical
Available on requestPrescription onlyUS FDAGeneric name

Hydrocortisone 2.5% ointment is a generic prescription medicine for topical use, made by 5 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 20-25°C (68-77°F).

Key facts

Active ingredient (INN)
Hydrocortisone
Brand
Sold under the generic name
Strength
2.5%
Dosage form
Ointment
Route
Topical
Packs
454 g, 29 g, 1 tube and 10 more
Manufacturers
Bryant Ranch PrepackE. FougeraPadagis Israel PharmaceuticalsA-S Medication SolutionsProficient Rx
Origin register
US FDA, United States
Storage
Store at 20-25°C (68-77°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
28 May 1993
Identifiers
RxCUI 103401, 310891DailyMed set ID 7ba59aa6-b828-4048-bf86-90c90d9894a0, a3fbdae4-d1dc-42de-939f-f9a7aab60e49, 848574fe-a23e-4e15-8c29-d624f50b71de +6NDC 45802-014, 50090-0527, 82804-084 +6Application ANDA085027, ANDA081203

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
454 g in 1 jar0168-0146-16E. Fougera28 May 1993
29 g in 1 tube0168-0146-30E. Fougera28 May 1993
1 tube in 1 carton / 20 g in 1 tube45802-014-02Padagis Israel Pharmaceuticals13 June 2006
454 g in 1 jar45802-014-05Padagis Israel Pharmaceuticals19 December 2006
454 g in 1 jar63629-2527-1Bryant Ranch Prepack19 December 2006
1 tube in 1 carton / 20 g in 1 tube63629-2528-1Bryant Ranch Prepack13 June 2006
29 g in 1 tube63629-8817-1Bryant Ranch Prepack10 September 2021
1 tube in 1 carton / 20 g in 1 tube63629-9057-1Bryant Ranch Prepack31 January 2007
1 tube in 1 carton / 20 g in 1 tube72162-1383-2Bryant Ranch Prepack26 September 2023
1 tube in 1 carton / 20 g in 1 tube72162-1383-4Bryant Ranch Prepack26 September 2023
454 g in 1 jar72162-1383-7Bryant Ranch Prepack26 September 2023
1 tube in 1 carton / 20 g in 1 tube50090-0527-0A-S Medication Solutions29 June 2016
1 tube in 1 carton / 20 g in 1 tube82804-084-20Proficient Rx19 March 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 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

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 2.5% ointment 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.