Prescription drug · NDA
Belrapzo (Bendamustine hydrochloride) NDC 42367-521
Bendamustine hydrochloride 100 mg/4mL · Injection · Intravenous · Eagle Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42367-521-25 | 4236705212542367052125 | 1 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25) / 4 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 3, 2019 |
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)
- Belrapzo
- Generic name (nonproprietary)
- bendamustine hydrochloride
- Active ingredients
- Bendamustine hydrochloride — 100 mg/4mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Eagle Pharmaceuticals, IncNDC labeler code 42367
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205580
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 42367-521_7e2a2a05-9122-41c0-acf0-a1231a57434eSPL ID 7e2a2a05-9122-41c0-acf0-a1231a57434eSPL set ID 9759a4ae-82ca-40cf-9c02-e1cadb21cbdcRxCUI 1726097, 2178266UNII 981Y8SX18MUPC 0342367521256
- 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
N442367052125followed by a unit qualifier and the quantityPackage 42367-0521-25. 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)
BELRAPZO 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) BELRAPZO 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) BELRAPZO is indicated for the treatment of patients with indolent B-cell non-Hod…
Excerpt only. Read the full label for complete information.
About NDC 42367-521
- What is NDC 42367-521?
- 42367-521 is the product NDC for Belrapzo (bendamustine hydrochloride), Bendamustine hydrochloride 100 mg/4mL injection, listed with the FDA by Eagle Pharmaceuticals, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Belrapzo (Bendamustine hydrochloride).
- What is the active ingredient?
- Bendamustine hydrochloride.
- Who is the labeler?
- Eagle Pharmaceuticals, Inc, NDC labeler code 42367. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Belrapzo?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.