Medicine
Fluorouracil 5000 mg/100 mL injection
Fluorouracil 5000 mg/100 mL injection is a generic prescription medicine for intravenous 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
DO NOT FREEZE. Store at 20°C to 25°C (68°F to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Fluorouracil
- Brand
- Sold under the generic name
- Strength
- 5000 mg/100 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 100 mL, 1 bottle of 100 mL and 12 more
- Manufacturers
- Alembic PharmaceuticalsIndiaEugiaIndiaAccord HealthcareIndiaAvet PharmaceuticalsIndiaGland PharmaIndiaFresenius KabiBluePoint LaboratoriesMeitheal PharmaceuticalsSagent PharmaceuticalsXiromed
- Origin register
- US FDA, United States
- Storage
- DO NOT FREEZE. Store at 20°C to 25°C (68°F to 77°F). Protect from light.
- 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
- 12 July 2000
- Identifiers
- RxCUI 239177, 1791701, 1791736DailyMed set ID b6b0d9e2-c6f0-4523-a33b-b958d32d3a28, 300304fa-4791-4455-962c-493ae467f504, 697816ce-dc05-4943-b7f0-2f0b125e93b7 +11NDC 46708-779, 68001-525, 55150-498 +10Application ANDA217676, ANDA210124, ANDA202669 +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 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 46708-779-31 | Alembic PharmaceuticalsIndia | 18 October 2023 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 62332-779-31 | Alembic PharmaceuticalsIndia | 18 October 2023 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 55150-498-01 | EugiaIndia | 8 April 2022 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 55150-499-01 | EugiaIndia | 8 April 2022 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 16729-276-38 | Accord HealthcareIndia | 14 March 2014 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 23155-975-31 | Avet PharmaceuticalsIndia | 7 September 2026 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 68083-293-01 | Gland PharmaIndia | 5 January 2018 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 63323-117-61 | Fresenius Kabi | 12 July 2000 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 63323-117-68 | Fresenius Kabi | 12 July 2000 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 63323-117-69 | Fresenius Kabi | 12 July 2000 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 71288-154-76 | Meitheal Pharmaceuticals | 6 February 2025 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 25021-215-99 | Sagent Pharmaceuticals | 15 September 2016 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 70700-189-22 | Xiromed | 13 August 2021 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 68001-525-32 | BluePoint Laboratories | 18 February 2022 |
| 1 vial, pharmacy bulk package in 1 carton / 100 mL in 1 vial, pharmacy bulk package | 68001-628-32 | BluePoint Laboratories | 31 January 2025 |
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 5000 mg/100 mL injection 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.