FDA.reportPublic FDA data

HepaGam B

Product NDC
70257-054
11-digit product format
702570054
Labeler code
70257
Product ID
70257-054_56525de0-f47d-11eb-85b4-0800200c9a66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
human hepatitis B virus immune globulin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Saol Therapeutics Inc.
Application
BLA125035
Marketing category
BLA
Marketing start
2018-06-20
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 productproduct70257-054DDiscontinued by firm2026-08-03
excluded packagepackage70257-05470257-054-51DDiscontinued by firm2026-08-03

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70257-054-05ML - Milliliter70257-0548f65b8a2-6809-4aa5-91ea-920a2ab28b9a12020-07-13
70257-054-51ML - Milliliter70257-054588dc743-460a-41e2-8bb8-30fc99c2c42712020-07-13

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
70257-054-51702570054511 VIAL, GLASS in 1 CARTON (70257-054-51) > 5 mL in 1 VIAL, GLASS (70257-054-05) 2018-06-200000-00-00NoNoCurrent