Medicine
Hydrocortisone valerate 0.2% cream
Hydrocortisone valerate 0.2% cream 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
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 valerate
- Brand
- Sold under the generic name
- Strength
- 0.2%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube and 13 more
- Manufacturers
- LupinIndiaSun Pharmaceutical IndustriesIndiaBryant Ranch PrepackCosette PharmaceuticalsEncube Ethicals
- 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
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 August 1998
- Identifiers
- RxCUI 1370754, 1370750DailyMed set ID 544dd7ac-ee59-418b-b3ef-10d682b582c4, a9011d6f-6808-48a7-ab6b-df8d40540570, fd68f7a2-fa0d-4d56-8e92-71cd955cc7a9 +4NDC 71335-2843, 51672-1290, 0713-0720 +4Application ANDA211047, ANDA075042, ANDA213724 +1
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 tube in 1 carton / 15 g in 1 tube | 68180-954-01 | LupinIndia | 19 November 2019 |
| 1 tube in 1 carton / 45 g in 1 tube | 68180-954-02 | LupinIndia | 19 November 2019 |
| 1 tube in 1 carton / 60 g in 1 tube | 68180-954-03 | LupinIndia | 19 November 2019 |
| 1 tube in 1 carton / 15 g in 1 tube | 51672-1290-1 | Sun Pharmaceutical IndustriesIndia | 25 August 1998 |
| 1 tube in 1 carton / 60 g in 1 tube | 51672-1290-3 | Sun Pharmaceutical IndustriesIndia | 25 August 1998 |
| 1 tube in 1 carton / 45 g in 1 tube | 51672-1290-6 | Sun Pharmaceutical IndustriesIndia | 25 August 1998 |
| 1 tube in 1 carton / 15 g in 1 tube | 0713-0720-15 | Cosette Pharmaceuticals | 1 July 2021 |
| 1 tube in 1 carton / 45 g in 1 tube | 0713-0720-37 | Cosette Pharmaceuticals | 1 July 2021 |
| 1 tube in 1 carton / 60 g in 1 tube | 0713-0720-60 | Cosette Pharmaceuticals | 1 July 2021 |
| 1 tube in 1 carton / 15 g in 1 tube | 21922-007-04 | Encube Ethicals | 31 December 2022 |
| 1 tube in 1 carton / 45 g in 1 tube | 21922-007-06 | Encube Ethicals | 31 December 2022 |
| 1 tube in 1 carton / 60 g in 1 tube | 21922-007-07 | Encube Ethicals | 31 December 2022 |
| 1 tube in 1 carton / 60 g in 1 tube | 71335-2723-1 | Bryant Ranch Prepack | 29 July 2025 |
| 1 tube in 1 carton / 15 g in 1 tube | 71335-2843-1 | Bryant Ranch Prepack | 22 October 2025 |
| 1 tube in 1 carton / 45 g in 1 tube | 72162-2301-4 | Bryant Ranch Prepack | 31 December 2022 |
| 1 tube in 1 carton / 60 g in 1 tube | 72162-2301-6 | Bryant Ranch Prepack | 31 December 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 17 March 1978 | 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 valerate
Clinical summary
Hydrocortisone valerate is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients. It is available as cream and ointment for topical use. MedsAcross supplies Hydrocortisone valerate 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 valerateFor 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 VALERATE prescribing information (Lupin) · U.S. National Library of Medicine, DailyMed
Need Hydrocortisone valerate 0.2% cream 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.