Medicine
Adapalene and Benzoyl peroxide 3 mg/25 mg per g gel
Adapalene and Benzoyl peroxide 3 mg/25 mg per g gel is a generic prescription medicine for topical use, made by 9 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Adapalene and Benzoyl peroxide
- Brand
- Sold under the generic name
- Strength
- 3 mg/25 mg per g
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 bottle, 45 g and 12 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaBryant Ranch PrepackMayne PharmaPadagis Israel PharmaceuticalsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 October 2018
- Identifiers
- RxCUI 1663745DailyMed set ID 05babd5f-18ab-4646-8962-cb000ed0f9a8, 92dcba02-f42f-482d-8cd5-2b5ab8fa540a, 91161d2f-8990-4268-bd74-f60cf33aa2a1 +8NDC 0480-3154, 45802-853, 63629-9322 +8Application ANDA209641, ANDA212464, ANDA214185 +4
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 bottle, pump in 1 carton / 45 g in 1 bottle, pump | 46708-662-45 | Alembic PharmaceuticalsIndia | 21 May 2025 |
| 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump | 62332-662-45 | Alembic PharmaceuticalsIndia | 10 August 2022 |
| 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump | 59651-604-46 | Aurobindo PharmaIndia | 22 July 2026 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 59651-604-60 | Aurobindo PharmaIndia | 22 July 2026 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 51672-1384-4 | Sun Pharmaceutical IndustriesIndia | 11 March 2021 |
| 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump | 51672-1384-9 | Sun Pharmaceutical IndustriesIndia | 17 October 2018 |
| 1 bottle, pump in 1 bottle, pump / 60 g in 1 bottle, pump | 72578-119-02 | Viona PharmaceuticalsIndia | 6 June 2022 |
| 1 bottle, pump in 1 bottle, pump / 45 g in 1 bottle, pump | 72578-119-04 | Viona PharmaceuticalsIndia | 6 June 2022 |
| 1 bottle, pump in 1 bottle, pump / 60 g in 1 bottle, pump | 70771-1716-3 | Zydus LifesciencesIndia | 6 June 2022 |
| 1 bottle, pump in 1 bottle, pump / 45 g in 1 bottle, pump | 70771-1716-4 | Zydus LifesciencesIndia | 6 June 2022 |
| 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump | 68308-662-45 | Mayne Pharma | 1 February 2022 |
| 45 g in 1 bottle, pump | 45802-853-45 | Padagis Israel Pharmaceuticals | 2 June 2022 |
| 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump | 0480-3154-45 | Teva Pharmaceuticals | 28 November 2022 |
| 45 g in 1 bottle, pump | 63629-9322-1 | Bryant Ranch Prepack | 7 July 2022 |
| 45 g in 1 bottle, pump | 72162-1432-2 | Bryant Ranch Prepack | 13 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 8 December 2008 | 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 Adapalene and Benzoyl peroxide
Clinical summary
Adapalene and Benzoyl peroxide is a fixed-dose combination medicine indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. MedsAcross supplies Adapalene and Benzoyl peroxide 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 Adapalene and Benzoyl peroxideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- adapalene and benzoyl peroxide prescribing information (Mayne Pharma) · U.S. National Library of Medicine, DailyMed
Need Adapalene and Benzoyl peroxide 3 mg/25 mg per g 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.