NDC codes

FDA NDC Directory
Product NDC (as listed)25021-242Labeler and product segments. Claims need a package NDC.
Product NDC at billing width25021-0242Add 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 NDC11-digit (billing)PackageCopy
25021-242-02250210242021 VIAL in 1 CARTON (25021-242-02) / 2 mL in 1 VIALMarketed from Oct 15, 2016

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
Sagent PharmaceuticalsNDC labeler code 25021
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076661
Marketing start
Listing expires
Other FDA classes
Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 25021-242_ec7f6839-a01c-4b1b-b4b3-5573037706ddSPL ID ec7f6839-a01c-4b1b-b4b3-5573037706ddSPL set ID 20e5acf0-90b7-45c8-be78-91eaf77c9ac0RxCUI 1740865UNII 1X9VK9O1SC
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

N425021024202 followed by a unit qualifier and the quantity

Package 25021-0242-02. 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 . 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 25021-242

What is NDC 25021-242?
25021-242 is the product NDC for Fludarabine Phosphate, Fludarabine phosphate 25 mg/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. 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?
Sagent Pharmaceuticals, NDC labeler code 25021. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Fludarabine PhosphateFludarabine phosphate 25 mg/mLInjection, SolutionIntravenousHisun Pharmaceuticals USA, Inc.42658-02442658-0024-01
Fludarabine PhosphateFludarabine phosphate 25 mg/mLInjectionIntravenousLannett Company, Inc.0527-124200527-1242-02
Fludarabine PhosphateFludarabine phosphate 25 mg/mLInjectionIntravenousAreva Pharmaceuticals59923-60459923-0604-02
Fludarabine phosphateFludarabine phosphate 50 mg/2mLInjection, Powder, Lyophilized, For solutionIntravenousActavis Pharma, Inc.45963-60945963-0609-55

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