NDC 0597-0197

Praxbind

Idarucizumab

Praxbind is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Idarucizumab.

• Product ID: 0597-0197_0f34052e-3feb-c2ea-c65d-6ab97e9b340d
• NDC: 0597-0197
• Product Type: Human Prescription Drug
• Proprietary Name: Praxbind
• Generic Name: Idarucizumab
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-10-21
• Marketing Category: BLA / BLA
• Application Number: BLA761025
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: IDARUCIZUMAB
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Humanized Monoclonal Antibody Fragment [EPC],Antibodies, Monoclonal, Humanized [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0597-0197-05

2 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05) > 50 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2015-10-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0197-05 [00597019705]

Praxbind INJECTION

• Marketing Category: BLA
• Application Number: BLA761025
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-10-21

Drug Details

Active Ingredients

Ingredient	Strength
IDARUCIZUMAB	50 mg/mL

OpenFDA Data

• SPL SET ID: c7400f8a-dcf4-a6df-6d07-983081b1bf34
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • 97RWB5S1U6
• RxNorm Concept Unique ID - RxCUI:
  • 1716200
  • 1716195

Pharmacological Class

• Humanized Monoclonal Antibody Fragment [EPC]
• Antibodies
• Monoclonal
• Humanized [CS]