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 ID69800-6503_0027260d-d075-4d86-bfb7-e4c31ee84423
NDC69800-6503
Product TypeHuman Prescription Drug
Proprietary NameBIVIGAM
Generic NameImmune Globulin Intravenous (human) 10%
Dosage FormLiquid
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-01-21
Marketing CategoryBLA / BLA
Application NumberBLA125389
Labeler NameADMA Biologics, Inc.
Substance NameHUMAN IMMUNOGLOBULIN G
Active Ingredient Strength10 g/100mL
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

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 Date2013-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69800-6503-1 [69800650301]

BIVIGAM LIQUID
Marketing CategoryBLA
Application NumberBLA125389
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-21

Drug Details

Active Ingredients

IngredientStrength
HUMAN IMMUNOGLOBULIN G10 g/100mL

OpenFDA Data

SPL SET ID:a2244aa0-a6d0-11df-b385-0002a5d5c51b
Manufacturer
UNII
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%"

    NDCBrand NameGeneric Name
    59730-6502BIVIGAMHUMAN IMMUNOGLOBULIN G
    59730-6503BIVIGAMHUMAN IMMUNOGLOBULIN G
    69800-6502BIVIGAMImmune Globulin Intravenous (Human) 10%
    69800-6503BIVIGAMImmune Globulin Intravenous (Human) 10%
    76125-918BIVIGAMHUMAN IMMUNOGLOBULIN G

    Trademark Results [BIVIGAM]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BIVIGAM
    BIVIGAM
    85533081 4318477 Live/Registered
    ADMA BIOMANUFACTURING, LLC
    2012-02-03
    BIVIGAM
    BIVIGAM
    77749249 not registered Dead/Abandoned
    Biotest Pharmaceuticals Corporation
    2009-06-01

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