What is fluorouracil used for?

Indications and Usage, quoted from the label by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (ANDA210123). Cross-references to other label sections are left out.

Fluorouracil is indicated for the treatment of patients with:

1.1 Adenocarcinoma of the Colon and Rectum

1.2 Adenocarcinoma of the Breast

1.3 Gastric Adenocarcinoma

1.4 Pancreatic Adenocarcinoma

Source: DailyMed label, set id f0b60247-89ff-42b5-a55b-61980c282749, version 1, effective August 14, 2026. NDC 23155-972, one of 36 listings for this product.

Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA090368). Cross-references to other label sections are left out.

Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.

The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with fluorouracil cream and solution is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.

Source: DailyMed label, set id acca0036-f19c-459b-9dfc-9592f1cd588d, version 11, effective July 14, 2026. NDC 51672-4118, one of 6 listings for this product.

Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA076526). Cross-references to other label sections are left out.

Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.

The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with fluorouracil topical solution is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure.

Source: DailyMed label, set id 1b2f6145-b338-42ed-88a7-f4da65c59164, version 7, effective July 15, 2026. NDC 51672-4062, one of 3 listings for this product.