Prescription drug · BLA
Bavencio (avelumab) NDC 44087-3535
Avelumab 20 mg/mL · Injection, Solution, Concentrate · Intravenous · EMD Serono, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44087-3535-1 | 44087353501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (44087-3535-1) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 23, 2017 |
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)
- Bavencio
- Generic name (nonproprietary)
- avelumab
- Active ingredients
- Avelumab — 20 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- EMD Serono, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761049
- Marketing start
- Listing expires
- Other FDA classes
- Monoclonal (Chemical structure)Programmed Death Ligand-1 Antagonists (Mechanism)Programmed Death Ligand-1-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 44087-3535_990c5dd1-5670-4e2f-af5d-6e87b73b12b5SPL ID 990c5dd1-5670-4e2f-af5d-6e87b73b12b5SPL set ID 5cd725a1-2fa4-408a-a651-57a7b84b2118RxCUI 1875542, 1875547UNII KXG2PJ551I
- Pharmacologic class
- Programmed Death Ligand-1 Blocker
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
N444087353501followed by a unit qualifier and the quantityPackage 44087-3535-01. 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)
BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for: Merkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC. ( 1.1 , 14.1 ) Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. ( 1.2 , 14.2 ) Patients with locally advanced or metastatic UC who: Have disease progression during or following platinum-containing chemotherapy. ( 1.2 , 14.2 ) Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. ( 1.2 , 14.2 ) Renal Cell Carcinoma (RCC) First-line …
Excerpt only. Read the full label for complete information.