NDC 44206-455

Hizentra

Human Immunoglobulin G

Hizentra is a Subcutaneous Liquid in the Plasma Derivative category. It is labeled and distributed by Csl Behring Ag. The primary component is Human Immunoglobulin G.

Product ID44206-455_6a80cdf3-dd64-4afa-b793-07be166ca17a
NDC44206-455
Product TypePlasma Derivative
Proprietary NameHizentra
Generic NameHuman Immunoglobulin G
Dosage FormLiquid
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2011-10-03
Marketing CategoryBLA / BLA
Application NumberBLA125350
Labeler NameCSL Behring AG
Substance NameHUMAN IMMUNOGLOBULIN G
Active Ingredient Strength0 g/mL
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 44206-455-10

1 VIAL, SINGLE-DOSE in 1 CARTON (44206-455-10) > 50 mL in 1 VIAL, SINGLE-DOSE (44206-455-93)
Marketing Start Date2011-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 44206-455-93 [44206045593]

HIZENTRA LIQUID
Marketing CategoryBLA
Application NumberBLA125350
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2011-10-03

NDC 44206-455-10 [44206045510]

HIZENTRA LIQUID
Marketing CategoryBLA
Application NumberBLA125350
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2011-10-03

Drug Details

Active Ingredients

IngredientStrength
HUMAN IMMUNOGLOBULIN G.2 g/mL

Pharmacological Class

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

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

NDCBrand NameGeneric Name
44206-451HizentraHUMAN IMMUNOGLOBULIN G
44206-452HizentraHUMAN IMMUNOGLOBULIN G
44206-454HizentraHUMAN IMMUNOGLOBULIN G
44206-455HizentraHUMAN IMMUNOGLOBULIN G
44206-456HizentraHUMAN IMMUNOGLOBULIN G
44206-458HizentraHizentra
44206-457HizentraHizentra
44206-417CarimuneHUMAN IMMUNOGLOBULIN G
44206-418CarimuneHUMAN IMMUNOGLOBULIN G
44206-436PrivigenHuman Immunoglobulin G
44206-437PrivigenHuman Immunoglobulin G
44206-438PrivigenHuman Immunoglobulin G
44206-439PrivigenHuman Immunoglobulin G

Trademark Results [Hizentra]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HIZENTRA
HIZENTRA
98746950 not registered Live/Pending
CSL Behring AG
2024-09-12
HIZENTRA
HIZENTRA
77672094 3822764 Live/Registered
CSL Behring AG
2009-02-17
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.