FDA.reportPublic FDA data

HepaGam B

Product NDC
70257-052
Requested package NDC
70257-052-51
11-digit product format
702570052
Labeler code
70257
Product ID
70257-052_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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70257-05270257-052-51DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70257-05270257-052-51DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70257-052-11ML - Milliliter70257-052a8169017-9a51-4367-a7cf-efe390e26b0712019-11-12
70257-052-51ML - Milliliter70257-052907d6e60-997e-42cb-85af-9cea24efa11212019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70257-052HEPAGAM 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
70257-052-51702570052511 VIAL, GLASS in 1 CARTON (70257-052-51) > 1 mL in 1 VIAL, GLASS (70257-052-11) 2019-03-010000-00-00NoNoCurrent