Medicine
Clindamycin and Tretinoin 12 mg/0.25 mg per g gel
Clindamycin and Tretinoin 12 mg/0.25 mg per g gel is a generic prescription medicine for topical 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 at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). •…
Key facts
- Active ingredient (INN)
- Clindamycin and Tretinoin
- Brand
- Sold under the generic name
- Strength
- 12 mg/0.25 mg per g
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 tube and 1 more
- Manufacturers
- Actavis PharmaOceanside Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). • Protect from light. • Protect from freezing. • Keep out of the reach of children. • Keep away from heat. • Keep tube tightly closed.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 July 2016
- Identifiers
- RxCUI 882548DailyMed set ID 63b2e85d-8fe5-4f18-9e85-8492c49a7520, 79e1c8f6-59cd-4efa-9efa-0762d4b1a10cNDC 68682-300, 0472-1790Application NDA050802, ANDA202564
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 / 30 g in 1 tube | 0472-1790-30 | Actavis Pharma | 5 July 2016 |
| 1 tube in 1 carton / 60 g in 1 tube | 0472-1790-60 | Actavis Pharma | 5 July 2016 |
| 1 tube in 1 carton / 30 g in 1 tube | 68682-300-30 | Oceanside Pharmaceuticals | 4 August 2020 |
| 1 tube in 1 carton / 60 g in 1 tube | 68682-300-60 | Oceanside Pharmaceuticals | 4 August 2020 |
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 7 November 2006 | 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
Alternatives
Other makers and brands of Clindamycin and Tretinoin 12 mg/0.25 mg per g gel.
Other strengths and forms of Clindamycin and Tretinoin
Clinical summary
Clindamycin and Tretinoin is a fixed-dose combination of a lincosamide antibacterial and a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years or older. MedsAcross supplies Clindamycin and Tretinoin 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 Clindamycin and TretinoinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZIANA prescribing information (Bausch Health) · U.S. National Library of Medicine, DailyMed
Need Clindamycin and Tretinoin 12 mg/0.25 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.