Prescription drug · ANDA
Fludarabine Phosphate NDC 42658-024
Fludarabine phosphate 25 mg/mL · Injection, Solution · Intravenous · Hisun Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42658-024-01 | 4265800240142658002401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (42658-024-01) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 1, 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)
- Fludarabine Phosphate
- Generic name (nonproprietary)
- fludarabine phosphate
- Active ingredients
- Fludarabine phosphate — 25 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hisun Pharmaceuticals USA, Inc.NDC labeler code 42658
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220196
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 42658-024_5b82547e-11ca-a21a-e063-6294a90a025bSPL ID 5b82547e-11ca-a21a-e063-6294a90a025b
- 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
N442658002401followed by a unit qualifier and the quantityPackage 42658-0024-01. 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.
About NDC 42658-024
- What is NDC 42658-024?
- 42658-024 is the product NDC for Fludarabine Phosphate, Fludarabine phosphate 25 mg/mL injection, solution, listed with the FDA by Hisun Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fludarabine Phosphate.
- What is the active ingredient?
- Fludarabine phosphate.
- Who is the labeler?
- Hisun Pharmaceuticals USA, Inc., NDC labeler code 42658. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fludarabine Phosphate?
- 4 other product NDCs are listed under this name. See all Fludarabine Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fludarabine Phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fludarabine Phosphate | Fludarabine phosphate 25 mg/mL | InjectionIntravenous | Lannett Company, Inc. | 0527-1242 | 00527-1242-02 |
| Fludarabine Phosphate | Fludarabine phosphate 25 mg/mL | InjectionIntravenous | Areva Pharmaceuticals | 59923-604 | 59923-0604-02 |
| Fludarabine Phosphate | Fludarabine phosphate 25 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-242 | 25021-0242-02 |
| Fludarabine phosphate | Fludarabine phosphate 50 mg/2mL | Injection, Powder, Lyophilized, For solutionIntravenous | Actavis Pharma, Inc. | 45963-609 | 45963-0609-55 |