FDA.reportPublic FDA data

HepaGam B 312 UNT in 1 ML Injection

RxCUI
1658159
RxNorm name
HepaGam B 312 UNT in 1 ML Injection
Display name
HepaGam B 312 UNT in 1 ML Injection
Full name
HepaGam B 312 UNT in 1 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125035Hepagam BHepatitis B Immune Globulin (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
0146011c-944b-4251-8a5f-e573a3d5f8c0HepaGam B > 312 UNT/ML in 1 ML Injection [PSN] · 1 ML hepatitis B immune globulin 312 UNT/ML Injection [HepaGam B] [SBD] · 1 ML HepaGam B 312 UNT/ML Injection [SY] · HepaGam B 312 UNT in 1 ML Injection [SY]44These highlights do not include all the information needed to use HepaGam B ® safely and effectively. See full prescribing information for HepaGam B ® . HepaGam B ® [Hepatitis B Immune Globulin Intravenous (Human)], Sterile Solution for Intravenous or Intramuscular Injection Solvent/Detergent Treated and Filtered. greater than 312 international units per milliliter (Measured potency stamped on the vial label) Initial U.S. Approval: 200620260302