Prescription drug · BLA
Lunsumio (Mosunetuzumab) NDC 50242-159
Mosunetuzumab 1 mg/mL · Concentrate · Intravenous · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-159-01 | 50242015901 | 1 VIAL in 1 CARTON (50242-159-01) / 1 mL in 1 VIALMarketed from Dec 22, 2022 |
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)
- Lunsumio
- Generic name (nonproprietary)
- mosunetuzumab
- Active ingredients
- Mosunetuzumab — 1 mg/mL
- Dosage form
- Concentrate
- Route
- Intravenous
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761263
- Marketing start
- Listing expires
- Identifiers
- Product ID 50242-159_492d93a0-02ba-4424-a425-1965749094f6SPL ID 492d93a0-02ba-4424-a425-1965749094f6SPL set ID 2ef0cf38-101c-4681-98fe-c05dc9ead443RxCUI 2625129, 2625135, 2625137, 2625138UNII LDJ89SS0YG
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
N450242015901followed by a unit qualifier and the quantityPackage 50242-0159-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (1…
Excerpt only. Read the full label for complete information.
About NDC 50242-159
- What is NDC 50242-159?
- 50242-159 is the product NDC for Lunsumio (mosunetuzumab), Mosunetuzumab 1 mg/mL concentrate, listed with the FDA by Genentech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lunsumio (Mosunetuzumab).
- What is the active ingredient?
- Mosunetuzumab.
- Who is the labeler?
- Genentech, Inc., NDC labeler code 50242. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lunsumio?
- 1 other product NDC are listed under this name. See all Lunsumio NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lunsumio products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lunsumiomosunetuzumab | Mosunetuzumab 30 mg/30mL | ConcentrateIntravenous | Genentech, Inc. | 50242-142 | 50242-0142-01 |
Other NDCs under BLA 761263
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 |
|---|---|---|---|---|
| Lunsumiomosunetuzumab | Mosunetuzumab 30 mg/30mL | ConcentrateIntravenous | Genentech, Inc. | 50242-142 |
| Lunsumio Velomosunetuzumab | Mosunetuzumab 5 mg/.5mL | InjectionSubcutaneous | Genentech, Inc. | 50242-177 |
| Lunsumio Velomosunetuzumab | Mosunetuzumab 45 mg/mL | InjectionSubcutaneous | Genentech, Inc. | 50242-201 |