NDC 64764-300

Entyvio

Vedolizumab

Entyvio is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Vedolizumab.

• Product ID: 64764-300_006da1d8-e01f-48fe-92d8-2f3f6bc16cac
• NDC: 64764-300
• Product Type: Human Prescription Drug
• Proprietary Name: Entyvio
• Generic Name: Vedolizumab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-05-20
• Marketing Category: BLA / BLA
• Application Number: BLA125476
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: VEDOLIZUMAB
• Active Ingredient Strength: 300 mg/5mL
• Pharm Classes: Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 64764-300-20

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

• Marketing Start Date: 2014-05-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64764-300-20 [64764030020]

Entyvio INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125476
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-05-20

Drug Details

Active Ingredients

Ingredient	Strength
VEDOLIZUMAB	300 mg/5mL

OpenFDA Data

• SPL SET ID: 6e94621c-1a95-4af9-98d1-52b9e6f1949c
• Manufacturer:
  • Takeda Pharmaceuticals America, Inc.
• UNII:
  • 9RV78Q2002
• RxNorm Concept Unique ID - RxCUI:
  • 1538137
  • 1538142

Pharmacological Class

• Integrin Receptor Antagonist [EPC]
• Integrin Receptor Antagonists [MoA]