Fludarabine Phosphate NDC 59923-604

NDC codes

FDA NDC Directory

Product NDC (as listed)59923-604Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59923-0604Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
59923-604-02	59923060402	1 VIAL, SINGLE-DOSE in 1 CARTON (59923-604-02) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 31, 2019

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
Route: Intravenous
Labeler: Areva Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090724
Marketing start: Dec 31, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 59923-604_f4b6988f-58a9-4593-e053-2a95a90afe36SPL ID f4b6988f-58a9-4593-e053-2a95a90afe36SPL set ID 8039c2e3-ffe5-3997-e053-2991aa0ad9d0RxCUI 1740865UNII 1X9VK9O1SCUPC 0359923604025
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.

How CPT relates to drug billing

NDC on a medical claim

N459923060402 followed by a unit qualifier and the quantity

Package 59923-0604-02. 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 Feb 14, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. Benefit in treatment-naïve or non-refractory CLL patients is not established. (1.1) 1.1 Indication Fludarabine Phosphate Injection is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of F…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090724

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090724
Product	Strength	Form · route	Labeler	Product NDC
Fludarabine Phosphate	Fludarabine phosphate 25 mg/mL	InjectionIntravenous	Lannett Company, Inc.	0527-1242