FDA.reportPublic FDA data

HepaGam B

Product NDC
70257-051
11-digit product format
702570051
Labeler code
70257
Product ID
70257-051_239012ee-5f14-4aed-9b1d-4e3e3283406f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hepatitis B Immune Globulin Intravenous (Human)
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Saol Therapeutics Inc.
Application
BLA125035
Marketing category
BLA
Marketing start
2019-03-01
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
2022-12-31
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 productproduct70257-051DDiscontinued by firm2026-08-03
excluded packagepackage70257-05170257-051-51DDiscontinued by firm2026-08-03

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70257-051-05ML - Milliliter70257-051357ceb55-0e95-4de4-9680-54bc4845262512019-04-11
70257-051-51ML - Milliliter70257-051a0d823f3-ce16-4c5a-8f84-1c191f14b5f112019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70257-051HEPAGAM B (HEPATITIS B IMMUNE GLOBULIN INTRAVENOUS (HUMAN)) INJECTION [SAOL THERAPEUTICS INC.]2Legacy NDC20210330_2ba8df27-4f35-41f6-8148-0c213c18df4e.zip

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70257-051-51702570051511 VIAL, GLASS in 1 CARTON (70257-051-51) > 5 mL in 1 VIAL, GLASS (70257-051-05) 2019-03-010000-00-00NoNoCurrent