FDA.reportPublic FDA data

HepaGam B

Product NDC
53270-0052
11-digit product format
532700052
Labeler code
53270
Product ID
53270-0052_148e1fa7-efc7-47be-a20a-1e9a623852e2
Type
PLASMA DERIVATIVE
Nonproprietary name
Hepatitis B Immune Globulin (Human)
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cangene bioPharma Inc.
Application
BLA125035
Marketing category
BLA
Marketing start
2010-08-01
Marketing end
0000-00-00
Substance
HUMAN HEPATITIS
Active strength
312 [iU]/mL
Pharmacologic classes
Human Immunoglo
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct53270-0052DDiscontinued by firm2026-08-03
excluded packagepackage53270-005253270-0052-1DDiscontinued by firm2026-08-03

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53270-0052-1ML - Milliliter53270-00520c810c3f-c18f-4ec0-b480-90afd91e113912012-07-24

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