Prescription drug · ANDA
Fluorouracil NDC 62332-779
Fluorouracil 50 mg/mL · Injection, Solution · Intravenous · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-779-31 | 62332077931 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (62332-779-31) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Oct 18, 2023 |
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
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217676
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 62332-779_60b3e5ab-03d4-4eae-b281-7880655d36e3SPL ID 60b3e5ab-03d4-4eae-b281-7880655d36e3
- 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
N462332077931followed by a unit qualifier and the quantityPackage 62332-0779-31. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 217676
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 | BluePoint Laboratories | 68001-628 |
| Fluorouracil | Fluorouracil 50 mg/mL | Injection, SolutionIntravenous | Alembic Pharmaceuticals Limited | 46708-779 |