TEVIMBRA
- Product NDC
- 72579-121
- 11-digit product format
- 725790121
- Labeler code
- 72579
- Product ID
- 72579-121_bc267296-25e7-42ee-a4d7-19b64f9fd279
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tislelizumab-jsgr
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- BeOne Medicines USA, Inc.
- Application
- BLA761232
- Marketing category
- BLA
- Marketing start
- 2024-03-14
- Substance
- TISLELIZUMAB
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TEVIMBRA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TISLELIZUMAB | 10 mg/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72579-121-01 | TEVIMBRA | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION, CONCENTRATE | 10 | | 12 |
| 72579-121-01 | TEVIMBRA | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72579-121 | TEVIMBRA (TISLELIZUMAB-JSGR) INJECTION, SOLUTION, CONCENTRATE [BEONE MEDICINES USA, INC.] | 6 | Current NDC, 2 package rows | 20250514_08ef1e3e-496f-4b0b-94ee-fbba3cc1985a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72579-121-01 | 72579012101 | 1 VIAL, GLASS in 1 CARTON (72579-121-01) / 10 mL in 1 VIAL, GLASS | 2024-03-14 | No | No | Historical |