FDA.reportPublic FDA data

hepatitis B immune globulin (human) > 312 UNT/ML in 5 ML Injection

RxCUI
1658125
RxNorm name
hepatitis B immune globulin (human) > 312 UNT/ML in 5 ML Injection
Display name
hepatitis B immune globulin (human) > 312 UNT/ML in 5 ML Injection
Full name
hepatitis B immune globulin (human) > 312 UNT/ML in 5 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125035Hepagam BHepatitis B Immune Globulin (Human)351(a)Rx2026-06-01
103945Nabi-HBHepatitis B Immune Globulin (Human)351(a)Disc2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nabi-HBHEPATITIS B IMMUNE GLOBULIN (HUMAN)ADMA Biologics, Inc.47fe1a99-5078-4b89-84fa-9e8387baec5c2025-04-10Warnings, Adverse reactionsExact identifier
rxcui: 1658125

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
47fe1a99-5078-4b89-84fa-9e8387baec5c5 ML hepatitis B immune globulin 312 UNT/ML InjectionSCD8Hepatitis B Immune Globulin (Human) Nabi-HB ® Solvent/Detergent Treated and Filtered20250410
47fe1a99-5078-4b89-84fa-9e8387baec5chepatitis B immune globulin (human) > 312 UNT/ML in 5 ML InjectionPSN8Hepatitis B Immune Globulin (Human) Nabi-HB ® Solvent/Detergent Treated and Filtered20250410
0146011c-944b-4251-8a5f-e573a3d5f8c0hepatitis B immune globulin (human) > 312 UNT/ML in 5 ML InjectionPSN4These 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
0146011c-944b-4251-8a5f-e573a3d5f8c05 ML hepatitis B immune globulin 312 UNT/ML InjectionSCD4These 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