Prescription drug · BLA
Monjuvi (Tafasitamab-cxix) NDC 50881-013
Tafasitamab 200 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Incyte Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50881-013-03 | 50881001303 | 1 VIAL in 1 CARTON (50881-013-03) / 5 mL in 1 VIALMarketed from Aug 5, 2020 |
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)
- Monjuvi
- Generic name (nonproprietary)
- tafasitamab-cxix
- Active ingredients
- Tafasitamab — 200 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Incyte CorporationNDC labeler code 50881
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761163
- Marketing start
- Listing expires
- Identifiers
- Product ID 50881-013_a70f85e0-c22b-419a-9be2-51f575932633SPL ID a70f85e0-c22b-419a-9be2-51f575932633SPL set ID 9e0a220b-517f-4c86-b581-ffbab493fb58RxCUI 2387338, 2387343UNII QQA9MLH692UPC 0350881013034
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
N450881001303followed by a unit qualifier and the quantityPackage 50881-0013-03. 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)
MONJUVI is a CD19-directed cytolytic antibody indicated: in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma …
Excerpt only. Read the full label for complete information.
About NDC 50881-013
- What is NDC 50881-013?
- 50881-013 is the product NDC for Monjuvi (tafasitamab-cxix), Tafasitamab 200 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Incyte Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Monjuvi (Tafasitamab-cxix).
- What is the active ingredient?
- Tafasitamab.
- Who is the labeler?
- Incyte Corporation, NDC labeler code 50881. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Monjuvi?
- 1 other product NDC are listed under this name. See all Monjuvi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Monjuvi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Monjuvitafasitamab-cxix | Tafasitamab 200 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Incyte Corporation | 73535-208 | 73535-0208-01 |
Other NDCs under BLA 761163
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 |
|---|---|---|---|---|
| Monjuvitafasitamab-cxix | Tafasitamab 200 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Incyte Corporation | 73535-208 |