NDC 50419-385

ALIQOPA

Copanlisib

ALIQOPA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Copanlisib.

• Product ID: 50419-385_12f30507-b918-4d5b-a44c-e0557e69f3bd
• NDC: 50419-385
• Product Type: Human Prescription Drug
• Proprietary Name: ALIQOPA
• Generic Name: Copanlisib
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-09-14
• Marketing Category: NDA / NDA
• Application Number: NDA209936
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: COPANLISIB
• Active Ingredient Strength: 15 mg/mL
• Pharm Classes: Kinase Inhibitor [EPC],Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50419-385-01

1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-01) > 4 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2017-09-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-385-72 [50419038572]

ALIQOPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA209936
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-30

NDC 50419-385-01 [50419038501]

ALIQOPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA209936
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-14

Drug Details

Active Ingredients

Ingredient	Strength
COPANLISIB	15 mg/mL

OpenFDA Data

• SPL SET ID: ade50241-2c10-4038-b4e9-72f6bf905f03
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • WI6V529FZ9
• RxNorm Concept Unique ID - RxCUI:
  • 1945086
  • 1945081

Pharmacological Class

• Kinase Inhibitor [EPC]
• Kinase Inhibitors [MoA]