NDC 50242-105

POLIVY

Polatuzumab Vedotin

POLIVY is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Polatuzumab Vedotin.

• Product ID: 50242-105_44775595-9a53-4064-9f80-6f490fca81ce
• NDC: 50242-105
• Product Type: Human Prescription Drug
• Proprietary Name: POLIVY
• Generic Name: Polatuzumab Vedotin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-06-10
• Marketing Category: BLA / BLA
• Application Number: BLA761121
• Labeler Name: Genentech, Inc.
• Substance Name: POLATUZUMAB VEDOTIN
• Active Ingredient Strength: 140 mg/7.52mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50242-105-01

1 VIAL, SINGLE-DOSE in 1 CARTON (50242-105-01) > 20 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-06-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-105-01 [50242010501]

POLIVY INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761121
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-10

Drug Details

Active Ingredients

Ingredient	Strength
POLATUZUMAB VEDOTIN	140 mg/7.52mL

OpenFDA Data

• SPL SET ID: 20a16ab2-f338-4abb-9dcd-254bd949a2bc
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • KG6VO684Z6
• RxNorm Concept Unique ID - RxCUI:
  • 2174100
  • 2174095

NDC Crossover Matching brand name "POLIVY" or generic name "Polatuzumab Vedotin"

NDC	Brand Name	Generic Name
50242-103	POLIVY	polatuzumab vedotin
50242-105	POLIVY	polatuzumab vedotin