Prescription drug · ANDA
Fluorouracil NDC 23155-974
Fluorouracil 50 mg/mL · Injection, Solution · Intravenous · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-974-31 | 23155097431 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (23155-974-31) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Sep 7, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fluorouracil
- Generic name (nonproprietary)
- fluorouracil
- Active ingredients
- Fluorouracil — 50 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210124
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 23155-974_158cf5e7-da4b-44df-b2f0-7bc6e82662d7SPL ID 158cf5e7-da4b-44df-b2f0-7bc6e82662d7SPL set ID b268684b-487f-4716-a2e8-6e6d3e117b14RxCUI 239177UNII U3P01618RTUPC 0323155974317
- Pharmacologic class
- Nucleoside Metabolic Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N423155097431followed by a unit qualifier and the quantityPackage 23155-0974-31. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
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 Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with Adenocarcinoma of the Colon and Rectum (1.1) Adenocarcinoma of the Breast (1.2) Gastric Adenocarcinoma (1.3) Pancreatic Adenocarcinoma (1.4)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210124
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fluorouracil | Fluorouracil 50 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-292 |
| Fluorouracil | Fluorouracil 50 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-293 |
| Fluorouracil | Fluorouracil 50 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-525 |
| Fluorouracil | Fluorouracil 50 mg/mL | Injection, SolutionIntravenous | Xiromed LLC | 70700-189 |
| Fluorouracil | Fluorouracil 50 mg/mL | Injection, SolutionIntravenous | Xiromed LLC | 70700-188 |
| Fluorouracil | Fluorouracil 50 mg/mL | Injection, SolutionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-975 |