NDC 42747-761

POTELIGEO

Mogamulizumab-kpkc

POTELIGEO is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Kyowa Kirin, Inc.. The primary component is Mogamulizumab.

• Product ID: 42747-761_04558692-b445-4aaa-aa7a-bb7a392a24e7
• NDC: 42747-761
• Product Type: Human Prescription Drug
• Proprietary Name: POTELIGEO
• Generic Name: Mogamulizumab-kpkc
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-08-08
• Marketing Category: BLA / BLA
• Application Number: BLA761051
• Labeler Name: Kyowa Kirin, Inc.
• Substance Name: MOGAMULIZUMAB
• Active Ingredient Strength: 4 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 42747-761-01

1 VIAL, GLASS in 1 CARTON (42747-761-01) > 5 mL in 1 VIAL, GLASS

• Marketing Start Date: 2018-08-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42747-761-01 [42747076101]

POTELIGEO INJECTION

• Marketing Category: BLA
• Application Number: BLA761051
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-08-08

Drug Details

Active Ingredients

Ingredient	Strength
MOGAMULIZUMAB	4 mg/mL

OpenFDA Data

• SPL SET ID: e53960ab-42a1-40d1-9c7d-eb013fe7f18f
• Manufacturer:
  • Kyowa Kirin, Inc.
• UNII:
  • YI437801BE
• RxNorm Concept Unique ID - RxCUI:
  • 2054086
  • 2054081