NDC 70257-310

WinRho SDF

Rho (d) Immune Globulin

WinRho SDF is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Saol Therapeutics Inc.. The primary component is Human Rho(d) Immune Globulin.

Product ID70257-310_40b487d4-5658-437b-99de-c0130d5d6bbb
NDC70257-310
Product TypeHuman Prescription Drug
Proprietary NameWinRho SDF
Generic NameRho (d) Immune Globulin
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2019-03-01
Marketing CategoryBLA / BLA
Application NumberBLA103649
Labeler NameSaol Therapeutics Inc.
Substance NameHUMAN RHO(D) IMMUNE GLOBULIN
Active Ingredient Strength5000 [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 70257-310-51

1 VIAL, SINGLE-DOSE in 1 CARTON (70257-310-51) > 1 INJECTION in 1 VIAL, SINGLE-DOSE (70257-310-04)
Marketing Start Date2019-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70257-310-04 [70257031004]

WinRho SDF INJECTION
Marketing CategoryBLA
Application NumberBLA103649
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-01

NDC 70257-310-51 [70257031051]

WinRho SDF INJECTION
Marketing CategoryBLA
Application NumberBLA103649
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-01

Drug Details

Active Ingredients

IngredientStrength
HUMAN IMMUNOGLOBULIN G5000 [iU]/1

OpenFDA Data

SPL SET ID:b8809e8b-9a6f-47d3-80de-fe46ae79f7cd
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 SDF" or generic name "Rho (d) Immune Globulin"

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

    Trademark Results [WinRho SDF]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    WINRHO SDF
    WINRHO SDF
    75327094 2183956 Dead/Cancelled
    CANGENE CORPORATION
    1997-07-18

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