NDC 64764-511 - 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: 64764-511
Package NDCs from labels: 64764-511-92
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
Label	Manufacturer	Effective date	Type
GAMMAGARD S/D	Takeda Pharmaceuticals America, Inc. \| Baxalta Belgium Manufacturing SA \| Baxter Healthcare Corporation \| Siegfried Hameln GmbH	2025-11-25	PLASMA DERIVATIVE

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64764-511	GAMMAGARD S/D (IMMUNE GLOBULIN INTRAVENOUS (HUMAN)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	11	Unmatched	20250409_bf8df9fd-bfdd-47c2-84d2-d91e50947bf6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HUMAN IMMUNOGLOBULIN G	ACTIVE INGREDIENT	66Y330CJHS	GAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]	2
HUMAN IMMUNOGLOBULIN G	ACTIVE MOIETY	66Y330CJHS	GAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]	2
ALBUMIN HUMAN	INACTIVE INGREDIENT	ZIF514RVZR	GAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]	2
ANHYDROUS DEXTROSE	INACTIVE INGREDIENT	5SL0G7R0OK	GAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]	2
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	GAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]	2
OCTOXYNOL-9	INACTIVE INGREDIENT	7JPC6Y25QS	GAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]	2
TRI-N-BUTYL PHOSPHATE	INACTIVE INGREDIENT	95UAS8YAF5	GAMMAGARD S/D (HUMAN IMMUNOGLOBULIN G) KIT [BAXTER HEALTHCARE CORPORATION]	2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 53 of 53 · 1,044 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	b3b4b176-41f0-4ca8-90d4-3fba5707564a	2014-02-21	Exact identifier unii: 451W47IQ8X
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21	Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.