NDC 59730-6503

BIVIGAM

Human Immunoglobulin G

BIVIGAM is a Intravenous Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Biotest Pharmaceuticals Corporation. The primary component is Human Immunoglobulin G.

Product ID59730-6503_7d627eaa-67e9-65e6-e053-2a91aa0a5833
NDC59730-6503
Product TypePlasma Derivative
Proprietary NameBIVIGAM
Generic NameHuman Immunoglobulin G
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-02-04
Marketing CategoryBLA / BLA
Application NumberBLA125389
Labeler NameBiotest Pharmaceuticals Corporation
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 59730-6503-1

100 mL in 1 VIAL, GLASS (59730-6503-1)
Marketing Start Date2013-02-04
Marketing End Date2021-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59730-6503-1 [59730650301]

BIVIGAM INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125389
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2013-02-04
Marketing End Date2021-09-30

Drug Details

Active Ingredients

IngredientStrength
HUMAN IMMUNOGLOBULIN G10 g/100mL

Pharmacological Class

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

NDC Crossover Matching brand name "BIVIGAM" or generic name "Human Immunoglobulin G"

NDCBrand NameGeneric Name
76125-918BIVIGAMBIVIGAM
59730-6503BIVIGAMBIVIGAM
59730-6502BIVIGAMBIVIGAM
69800-6503BIVIGAMBIVIGAM
69800-6502BIVIGAMBIVIGAM
44206-417CarimuneHUMAN IMMUNOGLOBULIN G
44206-418CarimuneHUMAN IMMUNOGLOBULIN G
44206-451HizentraHUMAN IMMUNOGLOBULIN G
44206-452HizentraHUMAN IMMUNOGLOBULIN G
44206-454HizentraHUMAN IMMUNOGLOBULIN G
44206-455HizentraHUMAN IMMUNOGLOBULIN G
44206-456HizentraHUMAN IMMUNOGLOBULIN G
44206-436PrivigenHuman Immunoglobulin G
44206-437PrivigenHuman Immunoglobulin G
44206-438PrivigenHuman Immunoglobulin G
44206-439PrivigenHuman 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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