Medicine
Hydrocortisone butyrate 1 mg/mL topical solution
Hydrocortisone butyrate 1 mg/mL topical solution is a generic prescription medicine for topical use, 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 at 20° to 25°C (68° to 77°F). Hydrocortisone Butyrate Cream USP, 0.1%…
Key facts
- Active ingredient (INN)
- Hydrocortisone butyrate
- Brand
- Sold under the generic name
- Strength
- 1 mg/mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 1 bottle
- Manufacturer
- Sun Pharmaceutical IndustriesIndia
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Hydrocortisone Butyrate Cream USP, 0.1%: Store at 20° to 25°C (68° to 77°F). Hydrocortisone Butyrate Topical Solution, 0.1%: 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
- D07AB02 Hydrocortisone butyrate
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 January 2004
- Identifiers
- RxCUI 1370758, 1370767, 1370770DailyMed set ID 51176835-598d-4da7-8a00-6bd36f52aa82NDC 51672-4061Application ANDA076364
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 20 mL in 1 bottle | 51672-4061-2 | Sun Pharmaceutical IndustriesIndia | 14 January 2004 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 51672-4061-4 | Sun Pharmaceutical IndustriesIndia | 14 January 2004 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 31 March 1982 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 butyrate
Clinical summary
Hydrocortisone butyrate is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It is available as lotion, ointment and cream for topical use. MedsAcross supplies Hydrocortisone butyrate 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 butyrateFor 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 Butyrate prescribing information (Oceanside Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Hydrocortisone butyrate 1 mg/mL topical solution 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.