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 table| Ingredient | Strength |
|---|
| VEDOLIZUMAB | 300 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9RV78Q2002 |
| Rxcui | 1538137, 1538142, 2667332, 2667336, 2667339, 2667342 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| VEDOLIZUMAB | ACTIVE INGREDIENT | 9RV78Q2002 | ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 1 | |
| VEDOLIZUMAB | ACTIVE MOIETY | 9RV78Q2002 | ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 1 | |
| ARGININE HYDROCHLORIDE | INACTIVE INGREDIENT | F7LTH1E20Y | ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 1 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 1 | |
| HISTIDINE MONOHYDROCHLORIDE | INACTIVE INGREDIENT | 1D5Q932XM6 | ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ENTYVIO (VEDOLIZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| 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#
Packages#
Package NDC, 11-digit format, Description table| 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 |