Prescription drug · BLA
Polivy (Polatuzumab vedotin) NDC 50242-105
Polatuzumab vedotin 140 mg/7.52mL · Injection, Powder, Lyophilized, For solution · Intravenous · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-105-01 | 50242010501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-105-01) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 10, 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)
- Polivy
- Generic name (nonproprietary)
- polatuzumab vedotin
- Active ingredients
- Polatuzumab vedotin — 140 mg/7.52mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761121
- Marketing start
- Listing expires
- Identifiers
- Product ID 50242-105_3916b425-789c-4223-bb91-1ee4b65ace41SPL ID 3916b425-789c-4223-bb91-1ee4b65ace41SPL set ID 20a16ab2-f338-4abb-9dcd-254bd949a2bcRxCUI 2174095, 2174100, 2398131, 2398133UNII KG6VO684Z6
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
N450242010501followed by a unit qualifier and the quantityPackage 50242-0105-01. 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 .
Indications (excerpt from the label)
POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. ( 1.1 ) in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies. ( 1.2 ) 1.1 Previously Untreated DLBCL, NOS or HGBL POLIVY in combination with a rituximab product, cyc…
Excerpt only. Read the full label for complete information.
About NDC 50242-105
- What is NDC 50242-105?
- 50242-105 is the product NDC for Polivy (polatuzumab vedotin), Polatuzumab vedotin 140 mg/7.52mL injection, powder, lyophilized, for solution, 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?
- Polivy (Polatuzumab vedotin).
- What is the active ingredient?
- Polatuzumab vedotin.
- 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 Polivy?
- 1 other product NDC are listed under this name. See all Polivy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Polivy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Polivypolatuzumab vedotin | Polatuzumab vedotin 30 mg/1.88mL | Injection, Powder, Lyophilized, For solutionIntravenous | Genentech, Inc. | 50242-103 | 50242-0103-01 |
Other NDCs under BLA 761121
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 |
|---|---|---|---|---|
| Polivypolatuzumab vedotin | Polatuzumab vedotin 30 mg/1.88mL | Injection, Powder, Lyophilized, For solutionIntravenous | Genentech, Inc. | 50242-103 |