Prescription drug · BLA
Tevimbra (tislelizumab-jsgr) NDC 72579-121
Tislelizumab 10 mg/mL · Injection, Solution, Concentrate · Intravenous · BeOne Medicines USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72579-121-01 | 72579012101 | 1 VIAL, GLASS in 1 CARTON (72579-121-01) / 10 mL in 1 VIAL, GLASSMarketed from Mar 14, 2024 |
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)
- Tevimbra
- Generic name (nonproprietary)
- tislelizumab-jsgr
- Active ingredients
- Tislelizumab — 10 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- BeOne Medicines USA, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761232
- Marketing start
- Listing expires
- Other FDA classes
- Programmed Death Receptor-1-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 72579-121_d46bfb2e-44c4-4a86-8a8f-b38fb01ac4b6SPL ID d46bfb2e-44c4-4a86-8a8f-b38fb01ac4b6SPL set ID 08ef1e3e-496f-4b0b-94ee-fbba3cc1985aRxCUI 2677432, 2677439, 2747128, 2747129UNII 0KVO411B3N
- Pharmacologic class
- Programmed Death Receptor-1 Blocking Antibody
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
N472579012101followed by a unit qualifier and the quantityPackage 72579-0121-01. 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)
TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for: Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). ( 1.1 ) as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. ( 1.1 ) Gastric Cancer in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction ade…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761232
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 |
|---|---|---|---|---|
| Tevimbratislelizumab-jsgr | Tislelizumab 10 mg/mL | Injection, Solution, ConcentrateIntravenous | BeOne Medicines USA, Inc. | 72579-125 |