Drug
Who makes fluorouracil?
20 companies list fluorouracil as a human prescription drug, including under the names Efudex, FAVLYXA, TOLAK. Forms: cream; injection, solution; solution. Routes: intravenous, topical.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing fluorouracil
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | injection, solution | ANDAANDA217295, ANDA217676 | 4 | 7 |
| GLAND PHARMA LIMITEDIndia | injection, solution | ANDAANDA210123, ANDA210124 | 4 | 4 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | injection, solution | ANDAANDA210123, ANDA210124 | 4 | 1 |
| Xiromed LLCIndia | injection, solution | ANDAANDA210123, ANDA210124 | 4 | 1 |
| BluePoint Laboratories Inc. | injection, solution | ANDAANDA210123, ANDA210124, ANDA217295 | 4 | 0 |
| Eugia US LLC | injection, solution | ANDAANDA202668, ANDA202669 | 4 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | cream; solution | ANDAANDA076526, ANDA090368 | 3 | 13 |
| Encube Ethicals LimitedIndia | cream; solution | ANDAANDA215612, ANDA216942 | 2 | 5 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | cream; injection, solution | ANDAANDA040743, ANDA214845 | 2 | 2 |
| Avyxa GmbHSwitzerland | injection, solution | NDANDA220201 | 2 | 1 |
| Meitheal Pharmaceuticals, Inc. | injection, solution | ANDAANDA215699, ANDA216494 | 2 | 0 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA040278 | 1 | 6 |
| ProPharma Distribution, LLC.United States | injection, solution | ANDAANDA040279 | 1 | 3 |
| Bausch Health US, LLCCanada | cream | NDANDA016831 | 1 | 1 |
| HILL DERMACEUTICALS, INC.United States | cream | NDANDA022259 | 1 | 1 |
| Mayne Pharma International Pty Ltd.Australia | cream | ANDAANDA077524 | 1 | 1 |
| Dr. Reddy's Labratories Inc. | cream | ANDAANDA077524 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | cream | NDA AUTHORIZED GENERICNDA016831 | 1 | 0 |
| Northstar Rx, LLC, | cream | ANDAANDA090368 | 1 | 0 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA203609 | 1 | 0 |
Bulk ingredient listings
- MEDISCA Inc.United States · 2 NDC
- Genvion CorporationCanada · 1 NDC
- IMCD Switzerland AGSwitzerland · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- Nantong Jinghua Pharmaceutical Co., LtdChina · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Enquiry
Common questions
- Who makes fluorouracil?
- 20 companies list fluorouracil as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, GLAND PHARMA LIMITED, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Xiromed LLC, BluePoint Laboratories Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Efudex?
- 16 companies list fluorouracil under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies fluorouracil active ingredient?
- 7 companies list fluorouracil as a bulk ingredient, including MEDISCA Inc., Genvion Corporation, IMCD Switzerland AG, LETCO MEDICAL, LLC.