Search by Drug Name or NDC

NDC 21922-0041-12 Fluorouracil 50 mg/mL Details

Fluorouracil 50 mg/mL

Fluorouracil is a TOPICAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Encube Ethicals Private Limited. The primary component is FLUOROURACIL.

MedlinePlus Drug Summary

Fluorouracil cream and topical solution are used to treat actinic or solar keratoses (scaly or crusted lesions [skin areas] caused by years of too much exposure to sunlight). Fluorouracil cream and topical solution are also used to treat a type of skin cancer called superficial basal cell carcinoma if usual types of treatment cannot be used. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing cells such as the abnormal cells in actinic keratoses and basal cell carcinoma.

Related Packages: 21922-0041-12
Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Fluorouracil Topical

Product Information

NDC	21922-0041
Product ID	21922-041_016537ca-bff8-4cc6-b956-e2d1cc1384cf
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Fluorouracil
Proprietary Name Suffix	n/a
Non-Proprietary Name	Fluorouracil
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	50
Active Ingredient Units	mg/mL
Substance Name	FLUOROURACIL
Labeler Name	Encube Ethicals Private Limited
Pharmaceutical Class	Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA215612
Listing Certified Through	2024-12-31

Package

NDC 21922-0041-12 (21922004112)

Pricing Information	N/A
NDC Package Code	21922-041-12
Billing NDC	21922004112
Package	1 BOTTLE in 1 CARTON (21922-041-12) / 10 mL in 1 BOTTLE
Marketing Start Date	2023-11-06
NDC Exclude Flag	N