NDC 0562-7805

RhoGAM Ultra-Filtered PLUS

Human Rho(d) Immune Globulin

RhoGAM Ultra-Filtered PLUS is a Intramuscular Injection, Solution in the Plasma Derivative category. It is labeled and distributed by Kedrion Melville Inc.. The primary component is Human Rho(d) Immune Globulin.

Product ID0562-7805_5524e781-b067-4334-924f-c2b8ec11803d
NDC0562-7805
Product TypePlasma Derivative
Proprietary NameRhoGAM Ultra-Filtered PLUS
Generic NameHuman Rho(d) Immune Globulin
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2007-03-09
Marketing CategoryBLA / BLA
Application NumberBLA103777
Labeler NameKedrion Melville Inc.
Substance NameHUMAN RHO(D) IMMUNE GLOBULIN
Active Ingredient Strength300 ug/1
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0562-7805-01

1 POUCH in 1 CARTON (0562-7805-01) > 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)
Marketing Start Date2007-03-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0562-7805-25 [00562780525]

Rhogam Ultra-Filtered Plus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103777
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date2007-03-09

NDC 0562-7805-00 [00562780500]

Rhogam Ultra-Filtered Plus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103777
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date2012-07-10

NDC 0562-7805-05 [00562780505]

Rhogam Ultra-Filtered Plus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103777
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date2007-03-09

NDC 0562-7805-01 [00562780501]

Rhogam Ultra-Filtered Plus INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103777
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date2007-03-09

Drug Details

Active Ingredients

IngredientStrength
HUMAN RHO(D) IMMUNE GLOBULIN300 ug/1

Pharmacological Class

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

NDC Crossover Matching brand name "RhoGAM Ultra-Filtered PLUS" or generic name "Human Rho(d) Immune Globulin"

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

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