Medicine
Azelaic acid 15% gel
Azelaic acid 15% gel is a generic prescription medicine for topical use, made by 6 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° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Azelaic acid
- Brand
- Sold under the generic name
- Strength
- 15%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 tube and 3 more
- Manufacturers
- Glenmark PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaActavis PharmaBryant Ranch PrepackEncube EthicalsSandoz
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D10AX03 Azelaic acid
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 October 2018
- Identifiers
- RxCUI 1041518DailyMed set ID ab3f174c-a3c4-4ae9-b0bc-954efaadf8de, 0b5ab22e-c78a-4429-9a76-a4ba2d11fcde, 66178511-5c1a-4ecd-bc98-2ceb54e710ac +3NDC 21922-038, 68462-626, 0781-7172 +3Application ANDA208724, ANDA204637, NDA021470 +2
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 / 50 g in 1 tube | 68462-626-52 | Glenmark PharmaceuticalsIndia | 19 November 2018 |
| 1 tube in 1 carton / 50 g in 1 tube | 51672-1389-3 | Sun Pharmaceutical IndustriesIndia | 23 August 2019 |
| 1 tube in 1 carton / 50 g in 1 tube | 0591-2131-55 | Actavis Pharma | 19 November 2018 |
| 1 tube in 1 carton / 50 g in 1 tube | 21922-038-14 | Encube Ethicals | 30 November 2023 |
| 1 tube in 1 carton / 50 g in 1 tube | 0781-7172-50 | Sandoz | 1 October 2018 |
| 1 tube in 1 carton / 50 g in 1 tube | 72162-2297-2 | Bryant Ranch Prepack | 30 November 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 13 September 1995 | 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 Azelaic acid
Clinical summary
Azelaic acid is a prescription medicine indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. It is available as gel, cream and foam for topical and cutaneous use. MedsAcross supplies Azelaic acid 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 Azelaic acidFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Azelaic Acid Gel prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
Need Azelaic acid 15% gel 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.