FDA.reportPublic FDA data

GAMMAGARD

Product NDC
0944-2625
11-digit product format
009442625
Labeler code
0944
Product ID
0944-2625_98ff91ce-550e-4c1d-a65a-74c10af4fe70
Type
PLASMA DERIVATIVE
Nonproprietary name
Immune Globulin Intravenous (Human)
Dosage form
KIT
Labeler
Baxalta US Inc.
Application
BLA103133
Marketing category
BLA
Marketing start
1994-05-10
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct0944-2625DDiscontinued by firm2026-07-31
excluded packagepackage0944-26250944-2625-03DDiscontinued by firm2026-07-31

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103133Gammagard, Gammagard S/D, IveegamImmune Globulin Intravenous (Human)351(a)Disc2026-06-01