NDC 44206-300

Rhophylac

Human Rho(d) Immune Globulin

Rhophylac is a Intramuscular; Intravenous Solution in the Plasma Derivative category. It is labeled and distributed by Csl Behring Ag. The primary component is Human Rho(d) Immune Globulin.

Product ID44206-300_03b4c36d-5ef7-4ce4-ad3d-d375a1347905
NDC44206-300
Product TypePlasma Derivative
Proprietary NameRhophylac
Generic NameHuman Rho(d) Immune Globulin
Dosage FormSolution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2009-01-06
Marketing CategoryBLA / BLA
Application NumberBLA125070
Labeler NameCSL Behring AG
Substance NameHUMAN RHO(D) IMMUNE GLOBULIN
Active Ingredient Strength1500 [iU]/2mL
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 44206-300-01

1 SYRINGE, GLASS in 1 CARTON (44206-300-01) > 2 mL in 1 SYRINGE, GLASS (44206-300-90)
Marketing Start Date2009-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 44206-300-01 [44206030001]

RHOPHYLAC SOLUTION
Marketing CategoryBLA
Application NumberBLA125070
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2009-01-06

NDC 44206-300-90 [44206030090]

RHOPHYLAC SOLUTION
Marketing CategoryBLA
Application NumberBLA125070
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2012-09-11

NDC 44206-300-10 [44206030010]

RHOPHYLAC SOLUTION
Marketing CategoryBLA
Application NumberBLA125070
Product TypePLASMA DERIVATIVE
Billing UnitML
Marketing Start Date2009-01-06

Drug Details

Active Ingredients

IngredientStrength
HUMAN RHO(D) IMMUNE GLOBULIN1500 [iU]/2mL

Pharmacological Class

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

NDC Crossover Matching brand name "Rhophylac" or generic name "Human Rho(d) Immune Globulin"

NDCBrand NameGeneric Name
44206-300RhophylacHUMAN RHO(D) IMMUNE GLOBULIN
0562-7806MICRhoGAM Ultra-Filtered PLUSHUMAN RHO(D) IMMUNE GLOBULIN
0562-7805RhoGAM Ultra-Filtered PLUSHUMAN RHO(D) IMMUNE GLOBULIN

Trademark Results [Rhophylac]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RHOPHYLAC
RHOPHYLAC
75099325 2131797 Live/Registered
CSL BEHRING AG
1996-05-06

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