What is NDC 0409-0801?

0409-0801 is the product NDC for Nipent (pentostatin), Pentostatin 2 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Hospira, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hospira, Inc., NDC labeler code 0409. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nipent?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nipent NDC 0409-0801 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0409-0801Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00409-0801Add 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
0409-0801-01	00409080101	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 15, 2007

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Nipent
Generic name (nonproprietary): pentostatin
Active ingredients: Pentostatin — 2 mg/mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Hospira, Inc.NDC labeler code 0409
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020122
Marketing start: Aug 15, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 0409-0801_5db62458-cb13-4a2a-b7ee-6ed3fca88a8cSPL ID 5db62458-cb13-4a2a-b7ee-6ed3fca88a8cSPL set ID 674e0e6d-46ed-4868-9196-04019d667716RxCUI 105607, 240573UNII 395575MZO7
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

N400409080101 followed by a unit qualifier and the quantity

Package 00409-0801-01. 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

Current FDA label (SPL), effective Jul 1, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0409-0801

What is NDC 0409-0801?: 0409-0801 is the product NDC for Nipent (pentostatin), Pentostatin 2 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Hospira, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nipent (Pentostatin).
What is the active ingredient?: Pentostatin.
Who is the labeler?: Hospira, Inc., NDC labeler code 0409. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nipent?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Nipent (Pentostatin) NDC 0409-0801