entyvio

Generic: vedolizumab

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name entyvio
Generic Name vedolizumab
Labeler takeda pharmaceuticals america, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

vedolizumab 300 mg/5mL

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-300
Product ID 64764-300_24e7cbcf-82ec-4276-ba13-e719bedf3ed2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125476
Listing Expiration 2027-12-31
Marketing Start 2014-05-20

Pharmacologic Class

Established (EPC)
integrin receptor antagonist [epc]
Mechanism of Action
integrin receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64764300
Hyphenated Format 64764-300

Supplemental Identifiers

RxCUI
1538137 1538142 2667332 2667336 2667339 2667342
UNII
9RV78Q2002
NUI
N0000175775 N0000175774

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name entyvio (source: ndc)
Generic Name vedolizumab (source: ndc)
Application Number BLA125476 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (64764-300-20) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

64764-300-20 1 VIAL, SINGLE-DOSE in 1 CARTON (64764-300-20) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

vedolizumab (300 mg/5mL)

Linked Drug Pages (1)

ENTYVIO, ENTYVIO Pen, Entyvio ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "24e7cbcf-82ec-4276-ba13-e719bedf3ed2", "openfda": {"nui": ["N0000175775", "N0000175774"], "unii": ["9RV78Q2002"], "rxcui": ["1538137", "1538142", "2667332", "2667336", "2667339", "2667342"], "spl_set_id": ["6e94621c-1a95-4af9-98d1-52b9e6f1949c"], "pharm_class_epc": ["Integrin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Integrin Receptor Antagonists [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (64764-300-20)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "64764-300-20", "marketing_start_date": "20140520"}], "brand_name": "Entyvio", "product_id": "64764-300_24e7cbcf-82ec-4276-ba13-e719bedf3ed2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Integrin Receptor Antagonist [EPC]", "Integrin Receptor Antagonists [MoA]"], "product_ndc": "64764-300", "generic_name": "vedolizumab", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Entyvio", "active_ingredients": [{"name": "VEDOLIZUMAB", "strength": "300 mg/5mL"}], "application_number": "BLA125476", "marketing_category": "BLA", "marketing_start_date": "20140520", "listing_expiration_date": "20271231"}