NDC 50633-120

DigiFab

Ovine Digoxin Immune Fab

DigiFab is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Btg International Inc.. The primary component is Ovine Digoxin Immune Fab.

• Product ID: 50633-120_23e6b396-31d3-46cd-e054-00144ff88e88
• NDC: 50633-120
• Product Type: Human Prescription Drug
• Proprietary Name: DigiFab
• Generic Name: Ovine Digoxin Immune Fab
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2001-08-31
• Marketing Category: BLA / BLA
• Application Number: BLA103910
• Labeler Name: BTG International Inc.
• Substance Name: OVINE DIGOXIN IMMUNE FAB
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Cardiac Glycoside [EPC],Cardiac Glycosides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50633-120-11

1 VIAL, GLASS in 1 CARTON (50633-120-11) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (50633-120-12)

• Marketing Start Date: 2001-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50633-120-11 [50633012011]

DigiFab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103910
• Product Type: PLASMA DERIVATIVE
• Billing Unit: EA
• Marketing Start Date: 2001-08-31

NDC 50633-120-12 [50633012012]

DigiFab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103910
• Product Type: PLASMA DERIVATIVE
• Marketing Start Date: 2019-12-07

Drug Details

Active Ingredients

Ingredient	Strength
OVINE DIGOXIN IMMUNE FAB	40 mg/1

OpenFDA Data

• SPL SET ID: c05ee6a5-c98b-45f4-83fd-40781639d653
• Manufacturer:
  • BTG International Inc.
• UNII:
  • YB12NQZ1YN
• RxNorm Concept Unique ID - RxCUI:
  • 349326
  • 404702
• UPC Code:
  • 0350633120119

Pharmacological Class

• Cardiac Glycoside [EPC]
• Cardiac Glycosides [CS]