Bleomycin (bleomycin sulfate) NDC 63323-137

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-137Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0137Add 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
63323-137-20	63323013720	1 VIAL in 1 CARTON (63323-137-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Feb 13, 2009

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): Bleomycin
Generic name (nonproprietary): bleomycin sulfate
Active ingredients: Bleomycin sulfate — 30 [USP'U]/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intramuscular, Intrapleural, Intravenous, Subcutaneous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065185
Marketing start: Feb 13, 2009
Listing expires: Dec 31, 2026
Identifiers: Product ID 63323-137_93aba071-101f-4610-90fa-27e3635b2c1cSPL ID 93aba071-101f-4610-90fa-27e3635b2c1cSPL set ID b5806c40-12ce-48e3-8abd-9f8997ef4428RxCUI 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

N463323013720 followed by a unit qualifier and the quantity

Package 63323-0137-20. 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 Oct 10, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Bleomycin for Injection, USP 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 for Injection 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 teratocarci…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065185

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

FDA NDC Directory listings under ANDA 065185
Product	Strength	Form · route	Labeler	Product NDC
Bleomycinbleomycin sulfate	Bleomycin sulfate 15 [USP'U]/1	Injection, Powder, Lyophilized, For solutionIntramuscular, Intrapleural, Intravenous, Subcutaneous	Fresenius Kabi USA, LLC	63323-136