Bleomycin NDC 0409-0323

NDC codes

FDA NDC Directory

Product NDC (as listed)0409-0323Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00409-0323Add 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
0409-0323-20	00409032320	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0323-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Apr 25, 2018

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): Bleomycin
Generic name (nonproprietary): bleomycin
Active ingredients: Bleomycin sulfate — 30 [USP'U]/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intramuscular, Intrapleural, Intravenous, Subcutaneous
Labeler: Hospira, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065031
Marketing start: Apr 25, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 0409-0323_d9e9c332-1b3f-469c-83b8-41e15183e635SPL ID d9e9c332-1b3f-469c-83b8-41e15183e635SPL set ID e629ba5a-4e08-4249-9551-af6dbd98a7e4RxCUI 1726673, 1726676UNII 7DP3NTV15T
Pharmacologic class: Cytoprotective Agent

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

N400409032320 followed by a unit qualifier and the quantity

Package 00409-0323-20. 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 Aug 25, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Squamous Cell Carcinoma Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to bleomycin is poorer in patients with previously irradiated head and neck cancer. Lymphomas Hodgkin's disease, non-Hodgkin's lymphoma. Testicular Carcinoma Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin has als…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065031

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

FDA NDC Directory listings under ANDA 065031
Product	Strength	Form · route	Labeler	Product NDC
Bleomycin	Bleomycin sulfate 30 [USP'U]/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous	Hospira, Inc.	61703-323
Bleomycin	Bleomycin sulfate 15 [USP'U]/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous	Hospira, Inc.	61703-332
Bleomycin	Bleomycin sulfate 15 [USP'U]/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous	Hospira, Inc.	0409-0332