NDC 0378-8078
Fluorouracil Cream
Fluorouracil
Fluorouracil Cream is a Topical Cream in the Human Prescription Drug category.  It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Fluorouracil.
| Product ID | 0378-8078_2e7939fa-eadb-459e-be03-99b74273b393 | 
| NDC | 0378-8078 | 
| Product Type | Human Prescription Drug | 
| Proprietary Name | Fluorouracil Cream | 
| Generic Name | Fluorouracil | 
| Dosage Form | Cream | 
| Route of Administration | TOPICAL | 
| Marketing Start Date | 2019-07-03 | 
| Marketing Category | NDA / NDA | 
| Application Number | NDA020985 | 
| Labeler Name | Mylan Pharmaceuticals Inc. | 
| Substance Name | FLUOROURACIL | 
| Active Ingredient Strength | 5 mg/g | 
| Pharm Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] | 
| NDC Exclude Flag | N | 
| Listing Certified Through | 2020-12-31 |