FDA.reportPublic FDA data

4.4 ML Rho(D) immune globulin, human 1136 UNT/ML Injection

RxCUI
1790382
RxNorm name
4.4 ML Rho(D) immune globulin, human 1136 UNT/ML Injection
Display name
4.4 ML Rho(D) immune globulin, human 1136 UNT/ML Injection
Full name
4.4 ML Rho(D) immune globulin, human 1136 UNT/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103649Winrho Sd, Winrho Sdf Liquid, Winrho Sdf LyophilizedRho(D) Immune Globulin Intravenous (Human)351(a)Disc2026-09-01

RxNav Current And Historical NDCs#

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UNII Substances#

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6erho(D) immune globulin, human 5000 UNT in 4.4 ML Injection [PSN] · 4.4 ML Rho(D) immune globulin, human 1136 UNT/ML Injection [SCD] · rho(D) immune globulin, human 5000 UNT per 4.4 ML Injection [SY]36These highlights do not include all the information needed to use WinRho ® SDF safely and effectively. See full prescribing information for WinRho ® SDF. WinRho ® SDF [Rh o (D) Immune Globulin Intravenous (Human)] Solution for Intravenous or Intramuscular Injection Initial U.S. Approval: 199520260416