FDA.reportPublic FDA data

GAMMAGARD

Product NDC
0944-2658
11-digit product format
009442658
Labeler code
0944
Product ID
0944-2658_123bfa78-6fbe-41c7-8e01-c885e58c1437
Type
PLASMA DERIVATIVE
Nonproprietary name
Immune Globulin Intravenous (Human)
Dosage form
KIT
Labeler
Takeda Pharmaceuticals America, Inc.
Application
BLA103133
Marketing category
BLA
Marketing start
1994-05-10
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GAMMAGARD
Brand name suffix
S/D
Listing expiration
2026-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-2658-04GAMMAGARDS/D1 in 1 CARTONKIT112
0944-2659-08GAMMAGARDS/D200 mL in 1 BOTTLEINJECTION, POWDER, LYOPHILIZED,200 mL50 mg in 1mL12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0944-2658-04EA - Each0944-2658ebbca41e-1af8-40c7-b81f-cddf1a09f4d112013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN IMMUNOGLOBULIN GACTIVE INGREDIENT66Y330CJHSGAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]2
HUMAN IMMUNOGLOBULIN GACTIVE MOIETY66Y330CJHSGAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]2
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRGAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]2
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKGAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]2
GLYCINEINACTIVE INGREDIENTTE7660XO1CGAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]2
OCTOXYNOL-9INACTIVE INGREDIENT7JPC6Y25QSGAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]2
TRI-N-BUTYL PHOSPHATEINACTIVE INGREDIENT95UAS8YAF5GAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-2658GAMMAGARD S/D (IMMUNE GLOBULIN INTRAVENOUS (HUMAN)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]11Current NDC, Legacy NDC, 2 package rows20250409_bf8df9fd-bfdd-47c2-84d2-d91e50947bf6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1809738GAMMAGARD 10 GM InjectionPSNbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809730GAMMAGARD 5 GM InjectionPSNbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809736immunoglobulin G, human 10 GM InjectionPSNbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809728immunoglobulin G, human 5 GM InjectionPSNbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809738immunoglobulin G, human 10000 MG Injection [Gammagard]SBDbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809730immunoglobulin G, human 5000 MG Injection [Gammagard]SBDbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809736immunoglobulin G, human 10000 MG InjectionSCDbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809728immunoglobulin G, human 5000 MG InjectionSCDbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809738Gammagard 10 GM InjectionSYbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809738Gammagard 10000 MG InjectionSYbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809730Gammagard 5 GM InjectionSYbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809730Gammagard 5000 MG InjectionSYbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809736immunoglobulin G, human 10 GM InjectionSYbf8df9fd-bfdd-47c2-84d2-d91e50947bf612
1809728immunoglobulin G, human 5 GM InjectionSYbf8df9fd-bfdd-47c2-84d2-d91e50947bf612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0944-2658-04009442658041 KIT in 1 CARTON (0944-2658-04) * 192 mL in 1 BOTTLE (0338-0001-37) * 192 mL in 1 BOTTLE (64764-511-92) * 200 mL in 1 BOTTLE (0944-2659-08) 1 kit1994-05-100000-00-00NoNoCurrent
0944-2659-0800944265908200 mL in 1 BOTTLE200 mlHistorical