Medicine
Fentanyl 50 mcg/hour transdermal patch
Fentanyl 50 mcg/hour transdermal patch is a generic prescription medicine for transdermal use, made by 4 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). Store in original unopened pouch. Store…
Key facts
- Active ingredient (INN)
- Fentanyl
- Brand
- Sold under the generic name
- Strength
- 50 mcg/hour
- Dosage form
- Transdermal patch
- Route
- Transdermal
- Packs
- 5 pouches and 1 more
- Manufacturers
- Aveva Drug Delivery SystemsIngenus PharmaceuticalsMylan PharmaceuticalsSpecGx
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Store in original unopened pouch. Store fentanyl transdermal system securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N01AH01 Fentanyl
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 January 2005
- Identifiers
- RxCUI 197696, 245134, 245135 +5DailyMed set ID 2a2238e9-4b5d-c56d-8663-dd354ff9ae0c, bf02ffd0-cc5d-446b-b648-378f6885052f, e15a7e9b-8025-49dd-9a6d-bafcccf1959f +1NDC 0378-9122, 50742-552, 0406-9150 +1Application ANDA076258, ANDA077449, ANDA077154
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 |
|---|---|---|---|
| 5 pouch in 1 carton / 1 patch in 1 pouch / 72 h in 1 patch | 3215-7704-05 | Aveva Drug Delivery Systems | 6 January 2025 |
| 5 pouch in 1 carton / 1 patch in 1 pouch / 72 h in 1 patch | 50742-552-05 | Ingenus Pharmaceuticals | 6 January 2025 |
| 5 pouch in 1 carton / 1 patch in 1 pouch / 72 h in 1 patch | 0378-9122-98 | Mylan Pharmaceuticals | 31 January 2005 |
| 5 pouch in 1 carton / 1 patch in 1 pouch / 72 h in 1 patch | 0406-9150-76 | SpecGx | 6 May 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.
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 Fentanyl
Clinical summary
Fentanyl is an opioid agonist indicated for analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. MedsAcross supplies Fentanyl 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 FentanylFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Fentanyl Citrate prescribing information (Phlow) · U.S. National Library of Medicine, DailyMed
- Effentora: European public assessment report (EPAR) · European Medicines Agency
- Instanyl: European public assessment report (EPAR) · European Medicines Agency
Need Fentanyl 50 mcg/hour transdermal patch 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.