NDC 70504-3300

WINRHO

Rho (d) Immune Globulin

WINRHO is a Intramuscular; Intravenous Liquid in the Human Prescription Drug category. It is labeled and distributed by Aptevo Biotherapeutics Llc. The primary component is Human Rho(d) Immune Globulin.

Product ID70504-3300_af5a44ab-5033-43c7-a3a4-eade9010bcbb
NDC70504-3300
Product TypeHuman Prescription Drug
Proprietary NameWINRHO
Generic NameRho (d) Immune Globulin
Dosage FormLiquid
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2016-07-01
Marketing CategoryBLA / BLA
Application NumberBLA103649
Labeler NameAptevo BioTherapeutics LLC
Substance NameHUMAN RHO(D) IMMUNE GLOBULIN
Active Ingredient Strength1500 [iU]/mL
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 70504-3300-2

1 VIAL, SINGLE-DOSE in 1 CARTON (70504-3300-2) > 1.3 mL in 1 VIAL, SINGLE-DOSE (70504-3300-1)
Marketing Start Date2016-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70504-3300-1 [70504330001]

WINRHO LIQUID
Marketing CategoryBLA
Application NumberBLA103649
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-07-01

NDC 70504-3300-2 [70504330002]

WINRHO LIQUID
Marketing CategoryBLA
Application NumberBLA103649
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-07-01

Drug Details

Active Ingredients

IngredientStrength
HUMAN IMMUNOGLOBULIN G1500 [iU]/mL

OpenFDA Data

SPL SET ID:c0948763-cfc2-49fc-86b0-76abcf036f70
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1790383
  • 1790382
  • 1790374
  • 1790506
  • 1790508
  • 1790379
  • 1790512
  • 1790513
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    70504-3000WINRHOrho (d) immune globulin
    70504-3100WINRHOrho (d) immune globulin
    70504-3300WINRHOrho (d) immune globulin
    70504-3500WINRHOrho (d) immune globulin
    70257-300WinRho SDFrho (d) immune globulin
    70257-310WinRho SDFrho (d) immune globulin
    70257-330WinRho SDFrho (d) immune globulin
    70257-350WinRho SDFrho (d) immune globulin

    Trademark Results [WINRHO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    WINRHO
    WINRHO
    73664870 1484984 Live/Registered
    WINNIPEG RH INSTITUTE INC., THE
    1987-06-05

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