ENTYVIO
- Product NDC
- 64764-107
- 11-digit product format
- 647640107
- Labeler code
- 64764
- Product ID
- 64764-107_266293d6-dd28-4e38-81c2-4f518d95ef5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vedolizumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- BLA761133
- Marketing category
- BLA
- Marketing start
- 2023-09-27
- Substance
- VEDOLIZUMAB
- Active strength
- 108 mg/.68mL
- Pharmacologic classes
- Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9RV78Q2002 | VEDOLIZUMAB | 943609-66-3 | VEDOLIZUMAB |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64764-107-11 | 64764010711 | 1 TRAY in 1 CARTON (64764-107-11) / 1 SYRINGE in 1 TRAY (64764-107-10) / .68 mL in 1 SYRINGE | 1 tray | 2023-09-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Entyvio | Takeda Pharmaceuticals America, Inc. | 2026-04-29 | HUMAN PRESCRIPTION DRUG LABEL | 26 |