Medicine
Hydrocortisone 100 mg/2 mL injection
Hydrocortisone 100 mg/2 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 2 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store unreconstituted product at 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Hydrocortisone
- Brand
- Sold under the generic name
- Strength
- 100 mg/2 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 1 vial of 2 mL
- Manufacturers
- Zydus LifesciencesIndiaCiplaIndia
- Origin register
- US FDA, United States
- Storage
- Store unreconstituted product at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store reconstituted and/or further diluted solution at controlled room temperature 20°C to 25°C (68°F to 77°F) and protect from light. If kept at controlled room temperature unused reconstituted and/or further diluted solution should be discarded after 12 hours post preparation.
- 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
- 25 September 2024
- Identifiers
- RxCUI 238755DailyMed set ID 37534164-9de5-4bb3-9f87-341dfcf90883, 451d6d04-b7d9-47d9-ba71-43cc5b9b3054, d533ebee-9f1c-42d7-9808-ae5d5e55741bNDC 70710-1907, 69097-004, 70771-1966Application ANDA217191, ANDA214050
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial in 1 carton / 2 mL in 1 vial | 70710-1907-1 | Zydus LifesciencesIndia | 9 May 2026 |
| 1 vial in 1 carton / 2 mL in 1 vial | 70771-1966-1 | Zydus LifesciencesIndia | 9 May 2026 |
| 1 vial in 1 carton / 2 mL in 1 vial | 69097-004-67 | CiplaIndia | 25 September 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.
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 HydrocortisoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Hydrocortisone prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Alkindi: European public assessment report (EPAR) · European Medicines Agency
- Efmody: European public assessment report (EPAR) · European Medicines Agency
Need Hydrocortisone 100 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.