NDC 69800-6503

BIVIGAM

Immune Globulin Intravenous (human) 10%

BIVIGAM is a Intravenous Liquid in the Human Prescription Drug category. It is labeled and distributed by Adma Biologics, Inc.. The primary component is Human Immunoglobulin G.

• Product ID: 69800-6503_0027260d-d075-4d86-bfb7-e4c31ee84423
• NDC: 69800-6503
• Product Type: Human Prescription Drug
• Proprietary Name: BIVIGAM
• Generic Name: Immune Globulin Intravenous (human) 10%
• Dosage Form: Liquid
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2013-01-21
• Marketing Category: BLA / BLA
• Application Number: BLA125389
• Labeler Name: ADMA Biologics, Inc.
• Substance Name: HUMAN IMMUNOGLOBULIN G
• Active Ingredient Strength: 10 g/100mL
• Pharm Classes: Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69800-6503-1

1 VIAL, SINGLE-USE in 1 CARTON (69800-6503-1) > 100 mL in 1 VIAL, SINGLE-USE (69800-6503-2)

• Marketing Start Date: 2013-01-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69800-6503-1 [69800650301]

BIVIGAM LIQUID

• Marketing Category: BLA
• Application Number: BLA125389
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-21

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN IMMUNOGLOBULIN G	10 g/100mL

OpenFDA Data

• SPL SET ID: a2244aa0-a6d0-11df-b385-0002a5d5c51b
• Manufacturer:
  • ADMA Biologics, Inc.
• UNII:
  • 66Y330CJHS
• RxNorm Concept Unique ID - RxCUI:
  • 1809422
  • 1809421
  • 1809416
  • 1809414
• UPC Code:
  • 0369800650212
  • 0369800650328
  • 0369800650311
  • 0369800650229

Pharmacological Class

• Human Immunoglobulin G [EPC]
• Passively Acquired Immunity [PE]
• Antigen Neutralization [MoA]
• Immunoglobulins [CS]
• Human Immunoglobulin G [EPC]
• Passively Acquired Immunity [PE]
• Antigen Neutralization [MoA]
• Immunoglobulins [CS]

NDC Crossover Matching brand name "BIVIGAM" or generic name "Immune Globulin Intravenous (human) 10%"

NDC	Brand Name	Generic Name
59730-6502	BIVIGAM	HUMAN IMMUNOGLOBULIN G
59730-6503	BIVIGAM	HUMAN IMMUNOGLOBULIN G
69800-6502	BIVIGAM	Immune Globulin Intravenous (Human) 10%
69800-6503	BIVIGAM	Immune Globulin Intravenous (Human) 10%
76125-918	BIVIGAM	HUMAN IMMUNOGLOBULIN G