FDA.reportPublic FDA data

NDC 0944-2657 - GAMMAGARD S/D

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0944-2657
Package NDCs from labels
0944-2657-07
Manufacturer
Takeda Pharmaceuticals America, Inc. | Baxalta Belgium Manufacturing SA | Baxter Healthcare Corporation | Siegfried Hameln GmbH
Effective date
2025-11-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GAMMAGARD S/DTakeda Pharmaceuticals America, Inc. | Baxalta Belgium Manufacturing SA | Baxter Healthcare Corporation | Siegfried Hameln GmbH2025-11-25PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-2657-07GAMMAGARDS/D100 mL in 1 BOTTLEINJECTION, POWDER, LYOPHILIZED,100 mL50 mg in 1mL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-2657GAMMAGARD S/D (IMMUNE GLOBULIN INTRAVENOUS (HUMAN)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]11Unmatched20250409_bf8df9fd-bfdd-47c2-84d2-d91e50947bf6.zip

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