Search by Drug Name or NDC
NDC 00378-4791-06 Fluorouracil 5 mg/g Details
Fluorouracil 5 mg/g
Fluorouracil is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. 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: 00378-4791-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluorouracil Topical
Product Information
| NDC | 00378-4791 |
|---|---|
| Product ID | 0378-4791_1ff72539-1af5-41bf-8720-1ba12df35abc |
| Associated GPIs | 90372030003730 |
| GCN Sequence Number | 007502 |
| GCN Sequence Number Description | fluorouracil CREAM (G) 5 % TOPICAL |
| HIC3 | Q5N |
| HIC3 Description | TOPICAL ANTINEOPLASTIC PREMALIGNANT LESION AGENTS |
| GCN | 30781 |
| HICL Sequence Number | 003907 |
| HICL Sequence Number Description | FLUOROURACIL |
| Brand/Generic | Generic |
| Proprietary Name | Fluorouracil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fluorouracil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/g |
| Substance Name | FLUOROURACIL |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA016831 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-4791-06 (00378479106)
| NDC Package Code | 0378-4791-06 |
|---|---|
| Billing NDC | 00378479106 |
| Package | 1 TUBE in 1 CARTON (0378-4791-06) / 40 g in 1 TUBE |
| Marketing Start Date | 2013-09-19 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.76114 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | FLUOROURACIL 5% CREAM |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5, 6 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis