Prescription drug · ANDA
Fluorouracil NDC 70700-189
Fluorouracil 50 mg/mL · Injection, Solution · Intravenous · Xiromed LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-189-22 | 70700018922 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70700-189-22) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Aug 13, 2021 |
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
- Labeler
- Xiromed LLC
- 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 70700-189_4b35e0c2-3335-94bf-e063-6394a90a9454SPL ID 4b35e0c2-3335-94bf-e063-6394a90a9454SPL set ID f4b0cae1-a2fc-2991-d663-3b729503cd1cRxCUI 239177UNII U3P01618RTUPC 0370700188224
- 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
N470700018922followed by a unit qualifier and the quantityPackage 70700-0189-22. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 | 70700-188 |
| Fluorouracil | Fluorouracil 50 mg/mL | Injection, SolutionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-974 |
| Fluorouracil | Fluorouracil 50 mg/mL | Injection, SolutionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-975 |