FDA.reportPublic FDA data

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-511GAMMAGARD 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

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 52 of 53 · 1,044 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
WinCo Foods Saline Nasal ReliefSODIUM CHLORIDEWinCo Foods, LLC1280fee4-e763-49ba-8722-8cdb8157f1a42018-08-02WarningsExact identifier
unii: 451W47IQ8X
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation05dee566-7b82-4216-8a6b-765d2b4d9dc72018-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: 451W47IQ8X
Metabolic SupportFUCUS VESICULOSUS, AGNUS CASTUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHYTOLACCA DECANDRA, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, CARBO VEGETABILIS, GRAPHITES, CALCAREA CARBONICA, NATRUM PHOSPHORICUM, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, THYROIDINUM (SUIS)BodyLogicMD of Fort Lauderdalec2a1bd6d-c595-402f-a3bc-23f64c949d782018-06-08WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation181705c7-40e4-4d7d-b9ea-ada99380e7a92018-05-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation7c72520e-de3c-493d-8aea-11933376d9682018-04-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDEBaxter Healthcare Company5215ec33-8cfe-4885-ae92-e6a12100bd272018-01-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GlycineGLYCINEBaxter Healthcare Corporationd4665408-04d8-4ad7-8589-708d4defb8692018-01-02Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Homeoplex BARSENICUM ALBUM, CALCAREA CARBONICA , IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA, STAPHYSAGRIASupplement Clinic, LLC.e9a9c58e-1b70-4ac8-9d9c-108c628d76642017-10-31WarningsExact identifier
unii: 451W47IQ8X
Spleen-Pro T018SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUSGuangzhou Renuma Medical Systems Co., Ltdbc2b70bd-2a4a-46fb-b3d8-d69b61056b892017-10-26WarningsExact identifier
unii: 451W47IQ8X
Female Vitality T010CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIAGuangzhou Renuma Medical Systems Co., Ltd694f0c36-b656-471a-9f38-2efb5193e05a2017-10-20WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company886f889b-f3cf-4197-b307-6cfa88c894362017-05-04Exact identifier
unii: 451W47IQ8X
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corp9883c502-9782-451e-9eec-c54d7b054f312017-01-31WarningsExact identifier
unii: 451W47IQ8X
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2a96096d-43cc-49b7-af53-b53c17f410012014-07-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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