Bendamustine (bendamustine hcl) NDC 71288-103

NDC codes

FDA NDC Directory

Product NDC (as listed)71288-103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71288-0103Add 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
71288-103-20	71288010320	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-103-20) / 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
Generic name (nonproprietary): bendamustine hcl
Active ingredients: Bendamustine hydrochloride — 100 mg/20mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Meitheal Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211001
Marketing start: Jun 5, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 71288-103_c4d02b46-b7dc-4c54-9f17-49f378437808SPL ID c4d02b46-b7dc-4c54-9f17-49f378437808SPL set ID 40f6f58d-d9ac-4f65-9fc7-16984bf1f180RxCUI 1805001, 1805007UNII 981Y8SX18M
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

N471288010320 followed by a unit qualifier and the quantity

Package 71288-0103-20. 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 May 11, 2026.

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 211001

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

FDA NDC Directory listings under ANDA 211001
Product	Strength	Form · route	Labeler	Product NDC
Bendamustinebendamustine hcl	Bendamustine hydrochloride 25 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-102