Prescription drug · NDA
Bendamustine Hydrochloride NDC 83831-183
Bendamustine hydrochloride 100 mg/4mL · Injection · Intravenous · Avyxa Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83831-183-04 | 83831018304 | 1 VIAL in 1 CARTON (83831-183-04) / 4 mL in 1 VIALMarketed from May 29, 2026 |
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/4mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Avyxa Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219014
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 83831-183_6c0bc00a-dd5f-4305-85d6-bd534e947e32SPL ID 6c0bc00a-dd5f-4305-85d6-bd534e947e32SPL set ID f359e7c6-d104-457d-a7fe-597c74440353RxCUI 1726097UNII 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.
- NDC on a medical claim
N483831018304followed by a unit qualifier and the quantityPackage 83831-0183-04. 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 .
Indications (excerpt from the label)
Bendamustine Hydrochloride Injection is an alkylating drug indicated for treatment of adult 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 Injection is indicated for the treatment of adult 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…
Excerpt only. Read the full label for complete information.