Entyvio
- Product NDC
- 64764-300
- 11-digit product format
- 647640300
- Labeler code
- 64764
- Product ID
- 64764-300_266293d6-dd28-4e38-81c2-4f518d95ef5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vedolizumab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- BLA125476
- Marketing category
- BLA
- Marketing start
- 2014-05-20
- Substance
- VEDOLIZUMAB
- Active strength
- 300 mg/5mL
- Pharmacologic classes
- Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Entyvio
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| VEDOLIZUMAB | 300 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9RV78Q2002 |
| Rxcui | 1538137, 1538142, 2667332, 2667336, 2667339, 2667342 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1736508a-7179-4f90-8972-12f94dcb872f | Product name | 2 | 20250624 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 1681bc73-b05f-12c3-1075-382ae39f449c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64764-300-20 | Entyvio | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | 26 | |
| 64764-300-20 | Entyvio | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | 26 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64764-300 | ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ENTYVIO PEN (VEDOLIZUMAB) INJECTION, SOLUTION ENTYVIO (VEDOLIZUMAB) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20240612_6e94621c-1a95-4af9-98d1-52b9e6f1949c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2667336 | ENTYVIO 108 MG in 0.68 ML Prefilled Syringe | PSN | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 1538142 | Entyvio 300 MG Injection | PSN | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667342 | ENTYVIO PEN 108 MG in 0.68 ML Auto-Injector | PSN | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667339 | vedolizumab 108 MG in 0.68 ML Auto-Injector | PSN | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667332 | vedolizumab 108 MG in 0.68 ML Prefilled Syringe | PSN | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 1538137 | vedolizumab 300 MG Injection | PSN | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667342 | 0.68 ML vedolizumab 159 MG/ML Auto-Injector [Entyvio] | SBD | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667336 | 0.68 ML vedolizumab 159 MG/ML Prefilled Syringe [Entyvio] | SBD | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 1538142 | vedolizumab 300 MG Injection [Entyvio] | SBD | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667339 | 0.68 ML vedolizumab 159 MG/ML Auto-Injector | SCD | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667332 | 0.68 ML vedolizumab 159 MG/ML Prefilled Syringe | SCD | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 1538137 | vedolizumab 300 MG Injection | SCD | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667342 | 0.68 ML Entyvio 159 MG/ML Auto-Injector | SY | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667336 | 0.68 ML Entyvio 159 MG/ML Prefilled Syringe | SY | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667342 | Entyvio 108 MG per 0.68 ML Auto-Injector | SY | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667336 | Entyvio 108 MG per 0.68 ML Prefilled Syringe | SY | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 1538142 | Entyvio 300 MG Injection | SY | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667339 | vedolizumab 108 MG per 0.68 ML Auto-Injector | SY | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
| 2667332 | vedolizumab 108 MG per 0.68 ML Prefilled Syringe | SY | 6e94621c-1a95-4af9-98d1-52b9e6f1949c | 26 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64764-300-20 | 64764030020 | 1 VIAL, SINGLE-DOSE in 1 CARTON (64764-300-20) / 5 mL in 1 VIAL, SINGLE-DOSE | 2014-05-20 | 0000-00-00 | No | No | Current |