Medicine
Fluorouracil 0.5% cream
Fluorouracil 0.5% cream 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)
- Fluorouracil
- Brand
- Sold under the generic name
- Strength
- 0.5%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaMylan 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).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01BC02 Fluorouracil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 September 2013
- Identifiers
- RxCUI 284191DailyMed set ID 744737c5-0d96-4214-82ab-6cff016b1ea0, 37dcfb83-0e7d-d23d-9cd5-afa5bdc30628NDC 0378-4791, 75907-169Application NDA016831, NDA020985
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 | 75907-169-11 | Dr. Reddy's LaboratoriesIndia | 6 July 2025 |
| 1 tube in 1 carton / 40 g in 1 tube | 0378-4791-06 | Mylan Pharmaceuticals | 19 September 2013 |
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 25 April 1962 | 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 Fluorouracil
Clinical summary
Fluorouracil is a nucleoside metabolic inhibitor. It is available as injection, cream and topical solution for intravenous use. MedsAcross supplies Fluorouracil 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 FluorouracilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Fluorouracil prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Fluorouracil 0.5% cream 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.