Medicine
Diclofenac epolamine 0.013 g transdermal system
Diclofenac epolamine 0.013 g transdermal system is a generic prescription medicine for topical use, made by 10 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 between 15°C to…
Key facts
- Active ingredient (INN)
- Diclofenac epolamine
- Brand
- Sold under the generic name
- Strength
- 0.013 g
- Dosage form
- Transdermal system
- Route
- Topical
- Packs
- 6 pouches, 3 pouches and 10 more
- Manufacturers
- AsclemedSportpharmYARAL PharmaAdvanced Rx of TennesseeAdvanced Rx Pharmacy of TennesseeHawaii RepackPhoenix RXPreferred PharmaceuticalsQuality Care ProductsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
- 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
- 1 May 2020
- Identifiers
- RxCUI 855626DailyMed set ID f4471245-83d0-49f5-9cd5-3f7e76c799c4, 08b8737f-b6d2-77da-e063-6294a90a1a3e, 45e191b6-c6c9-45f9-96d5-cf30f8aa910c +8NDC 76420-409, 80425-0364, 76420-673 +8Application NDA021234
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 |
|---|---|---|---|
| 6 pouch in 1 carton / 5 system in 1 pouch | 0093-3727-55 | Teva Pharmaceuticals | 1 May 2020 |
| 6 pouch in 1 carton / 5 system in 1 pouch | 82347-0405-5 | YARAL Pharma | 18 November 2022 |
| 3 pouch in 1 carton / 5 system in 1 pouch | 82347-0405-6 | YARAL Pharma | 15 January 2025 |
| 6 pouch in 1 carton / 5 system in 1 pouch | 76420-409-30 | Asclemed | 25 June 2025 |
| 6 pouch in 1 carton / 5 system in 1 pouch | 76420-673-30 | Asclemed | 26 February 2024 |
| 6 pouch in 1 carton / 5 system in 1 pouch | 80425-0364-1 | Advanced Rx of Tennessee | 27 November 2023 |
| 6 pouch in 1 carton / 5 system in 1 pouch | 80425-0403-1 | Advanced Rx Pharmacy of Tennessee | 19 June 2024 |
| 6 pouch in 1 carton / 5 system in 1 pouch | 85534-0034-0 | Hawaii Repack | 3 July 2026 |
| 6 pouch in 1 carton / 5 system in 1 pouch | 85509-1405-3 | Phoenix RX | 27 September 2025 |
| 6 pouch in 1 carton / 5 system in 1 pouch | 68788-4115-3 | Preferred Pharmaceuticals | 8 June 2026 |
| 6 pouch in 1 carton / 5 system in 1 pouch | 83008-036-30 | Quality Care Products | 15 August 2023 |
| 3 pouch in 1 carton / 5 system in 1 pouch | 85766-265-15 | Sportpharm | 24 August 2026 |
| 6 pouch in 1 carton / 5 system in 1 pouch | 85766-265-30 | Sportpharm | 24 August 2026 |
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 January 2007 | 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 Diclofenac epolamine 0.013 g transdermal system.
Clinical summary
Diclofenac epolamine is a nonsteroidal anti-inflammatory drug indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. MedsAcross supplies Diclofenac epolamine 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 Diclofenac epolamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- diclofenac epolamine prescribing information (Teva Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Diclofenac epolamine 0.013 g transdermal system for your hospital or patient?
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