NDC 13533-661

HYPERRHO S/D MINI-DOSE

Rho(d) Immune Globulin (human)

HYPERRHO S/D MINI-DOSE is a Intramuscular Solution in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Rho(d) Immune Globulin.

Product ID13533-661_1644da81-b047-418a-95b5-4ce1b4b3e3c8
NDC13533-661
Product TypePlasma Derivative
Proprietary NameHYPERRHO S/D MINI-DOSE
Generic NameRho(d) Immune Globulin (human)
Dosage FormSolution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date1996-08-14
Marketing CategoryBLA / BLA
Application NumberBLA101141
Labeler NameGRIFOLS USA, LLC
Substance NameHUMAN RHO(D) IMMUNE GLOBULIN
Active Ingredient Strength250 [iU]/1
Pharm ClassesHuman Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 13533-661-06

10 SYRINGE in 1 CARTON (13533-661-06) > 1 SOLUTION in 1 SYRINGE (13533-661-60)
Marketing Start Date1996-08-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13533-661-60 [13533066160]

HYPERRHO S/D MINI-DOSE SOLUTION
Marketing CategoryBLA
Application NumberBLA101141
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date1996-08-14

NDC 13533-661-06 [13533066106]

HYPERRHO S/D MINI-DOSE SOLUTION
Marketing CategoryBLA
Application NumberBLA101141
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date1996-08-14

Drug Details

Active Ingredients

IngredientStrength
HUMAN RHO(D) IMMUNE GLOBULIN250 [iU]/1

Pharmacological Class

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

NDC Crossover Matching brand name "HYPERRHO S/D MINI-DOSE" or generic name "Rho(d) Immune Globulin (human)"

NDCBrand NameGeneric Name
13533-631HYPERRHORHO(D) IMMUNE GLOBULIN (HUMAN)
13533-661HYPERRHORHO(D) IMMUNE GLOBULIN (HUMAN)

Trademark Results [HYPERRHO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYPERRHO
HYPERRHO
78622902 3206858 Live/Registered
GRIFOLS THERAPEUTICS LLC
2005-05-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.