Prescription drug · BLA
Bizengri (zenocutuzumab) NDC 71837-1000
Zenocutuzumab 20 mg/mL · Injection · Intravenous · Partner Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71837-1000-2 | 71837100002 | 2 VIAL, GLASS in 1 CARTON (71837-1000-2) / 18.75 mL in 1 VIAL, GLASS (71837-1000-1)Marketed from Dec 16, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Bizengri
- Generic name (nonproprietary)
- zenocutuzumab
- Active ingredients
- Zenocutuzumab — 20 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Partner Therapeutics, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761352
- Marketing start
- Listing expires
- Identifiers
- Product ID 71837-1000_777005ee-d019-4976-abb4-b998cf68e05fSPL ID 777005ee-d019-4976-abb4-b998cf68e05fSPL set ID 203daea4-fc87-40a4-a92f-ba2351b16de1RxCUI 2699594, 2699601UNII AE72RB1W1XUPC 0371837100028
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
N471837100002followed by a unit qualifier and the quantityPackage 71837-1000-02. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 ) Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. ( 1.3 ) *This indication is approved under …
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761352
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bizengrizenocutuzumab | Zenocutuzumab 20 mg/mL | InjectionIntravenous | Merus US, Inc. | 83077-100 |