What is NDC 45963-609?

45963-609 is the product NDC for Fludarabine phosphate, Fludarabine phosphate 50 mg/2mL injection, powder, lyophilized, for solution, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 45963. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fludarabine phosphate NDC 45963-609 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45963-609Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45963-0609Add 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
45963-609-55	45963060955	1 VIAL, GLASS in 1 CARTON (45963-609-55) / 2 mL in 1 VIAL, GLASSMarketed from Jan 5, 2015

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 — 50 mg/2mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Actavis Pharma, Inc.NDC labeler code 45963
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078610
Marketing start: Jan 5, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 45963-609_6ee71a09-01b9-4412-9048-a8ed9b6b0051SPL ID 6ee71a09-01b9-4412-9048-a8ed9b6b0051SPL set ID 3adca34b-4f65-4e21-8058-3c01fc7fc9bbRxCUI 1740864UNII 1X9VK9O1SCUPC 0345963609557
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

N445963060955 followed by a unit qualifier and the quantity

Package 45963-0609-55. 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 Sep 30, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fludarabine Phosphate for 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 Fludarabine Phosphate for Injection in previously untreated or non-refractory patients with CLL have not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45963-609

What is NDC 45963-609?: 45963-609 is the product NDC for Fludarabine phosphate, Fludarabine phosphate 50 mg/2mL injection, powder, lyophilized, for solution, listed with the FDA by Actavis Pharma, 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?: Actavis Pharma, Inc., NDC labeler code 45963. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fludarabine phosphate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fludarabine Phosphate	Fludarabine phosphate 25 mg/mL	Injection, SolutionIntravenous	Hisun Pharmaceuticals USA, Inc.	42658-024	42658-0024-01
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