Bendamustine Hydrochloride NDC 55150-392

NDC codes

FDA NDC Directory

Product NDC (as listed)55150-392Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55150-0392Add 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
55150-392-01	55150039201	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-392-01) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 5, 2023

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): Bendamustine Hydrochloride
Generic name (nonproprietary): bendamustine hydrochloride
Active ingredients: Bendamustine hydrochloride — 100 mg/20mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Eugia US LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214739
Marketing start: Jun 5, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 55150-392_4357b1f0-fcc2-448a-9580-13b55ba470deSPL ID 4357b1f0-fcc2-448a-9580-13b55ba470deSPL set ID dbe34bc1-06b2-493f-8859-e8b143357aa8RxCUI 1805001, 1805007UNII 981Y8SX18MUPC 0355150391011
Pharmacologic class: Alkylating Drug

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

N455150039201 followed by a unit qualifier and the quantity

Package 55150-0392-01. 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 5, 2023.

Indications (excerpt from the label)

Bendamustine hydrochloride for injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) Bendamustine hydrochloride for injection is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) Bendamustine hyd…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214739

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

FDA NDC Directory listings under ANDA 214739
Product	Strength	Form · route	Labeler	Product NDC
Bendamustine Hydrochloride	Bendamustine hydrochloride 25 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-391