FDA.reportPublic FDA data

HepaGam B

Product NDC
70504-0054
11-digit product format
705040054
Labeler code
70504
Product ID
70504-0054_b3195063-4432-4936-9597-43eed79f87cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hepatitis B Immune Globulin (Human)
Dosage form
SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Aptevo BioTherapeutics LLC
Application
BLA125035
Marketing category
BLA
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Active strength
312 [iU]/mL
Pharmacologic classes
Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70504-0054DDiscontinued by firm2026-08-03
excluded packagepackage70504-005470504-0054-2DDiscontinued by firm2026-08-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70504-0054-22023-02-01C16284748780-1d6a99b39-3698-a426-e053-dadaa90af4c2These 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. >312 IU per milliliter (Measured potency stamped on the vial label) Initial U.S. Approval: 2006
70504-0054-22022-01-28C16284748780-1d6a99b39-3698-a426-e053-dadaa90af4c2These 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. >312 IU per milliliter (Measured potency stamped on the vial label) Initial U.S. Approval: 2006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70504-0054-1ML - Milliliter70504-0054908e18df-7ced-4f28-ab6d-746092a326fa12018-07-03
70504-0054-2ML - Milliliter70504-0054043b4469-c251-4afa-be39-9d2d79fb204712018-07-03

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70504-0054-2705040054021 VIAL in 1 CARTON (70504-0054-2) > 5 mL in 1 VIAL (70504-0054-1) 1 vial2018-07-020000-00-00NoNoCurrent