FDA.reportPublic FDA data

Rhophylac 1500 UNT per 2 ML Prefilled Syringe

RxCUI
1117765
RxNorm name
Rhophylac 1500 UNT per 2 ML Prefilled Syringe
Display name
Rhophylac 1500 UNT per 2 ML Prefilled Syringe
Full name
Rhophylac 1500 UNT per 2 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:19

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125070RhophylacRho(D) Immune Globulin Intravenous (Human)351(a)Rx2026-09-01

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
c1b5d801-336f-4541-a7d9-a8d4a110a4ccRhophylac 1500 UNT in 2 ML Prefilled Syringe [PSN] · 2 ML Rho(D) immune globulin, human 750 UNT/ML Prefilled Syringe [Rhophylac] [SBD] · 2 ML Rhophylac 750 UNT/ML Prefilled Syringe [SY] · Rhophylac 1500 UNT per 2 ML Prefilled Syringe [SY]415These highlights do not include all the information needed to use RHOPHYLAC safely and effectively. See full prescribing information for RHOPHYLAC. RHOPHYLAC Rh 0 (D) Immune Globulin Intravenous (Human) 1500 IU (300 mcg) Solution for Intravenous (IV) or Intramuscular (IM) Injection Initial U.S. Approval: 200420250801