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 47 of 53 · 1,044 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cardioplegic SolutionPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEFresenius Kabi, USA, LLCeb360dc4-88d6-4b28-9b61-bc359e16bd222022-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.24a08a93-df23-474b-873e-c59ec8855f9f2022-03-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Wild Horse 777 Moisturizing NasalSODIUM CHLORIDEWild Horse 777, Inc.b0b4dadd-11fa-3dbb-e053-2995a90a20972022-03-14WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.cc14fafd-3dcd-4fc8-bdbd-6f355c3757682022-02-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC8b44bfd3-70a4-4b47-bc7b-590f63b8cc752022-02-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCf62481fd-fcdb-4be6-ac13-29c590e925c32022-02-10Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.e44c41ae-c9c8-4dd8-ba6c-cebb585378aa2022-01-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist WalgreensSODIUM CHLORIDEWALGREEN COMPANYd6b9d4fc-b758-be32-e053-2995a90a25232022-01-29WarningsExact identifier
unii: 451W47IQ8X
Extra Strenght Saline Mist Rite AidSODIUM CHLORIDERITE AID CORPORATIONd5b30fb2-4052-4a0c-e053-2a95a90aacd52022-01-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist Rite AidSODIUM CHLORIDERITE AIDd583067e-1133-7d7d-e053-2a95a90a1e362022-01-13WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Sterile Saline MistSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC648da2bc-bc91-4295-9e46-d3055cdc24182022-01-08WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Nasal DripSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INCd5129a91-50e7-6b94-e053-2a95a90a2b302022-01-08WarningsExact identifier
unii: 451W47IQ8X
SinuCleanse Sterile Saline Mist Daily CareSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INCd5131ab2-8213-3659-e053-2a95a90ab2ab2022-01-08WarningsExact identifier
unii: 451W47IQ8X
Headek NasalBELLADONNA, GLONOINUM, COFFEA, NATRUM CARB, NATRUM MUR.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics976b9c85-68c9-46a5-9012-53cb24683b032021-12-29WarningsExact identifier
unii: 451W47IQ8X
EAR RXACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUMMiami Beach Pediatrics paa8753f88-4b8a-472f-a4bd-f2e9cec836102021-12-29WarningsExact identifier
unii: 451W47IQ8X
Lyme Disease Support 1ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA.OHM PHARMA INC.035e75d6-aeef-4dfd-b076-9d3d8e4a50862021-12-29WarningsExact identifier
unii: 451W47IQ8X
Anxiety Stress ReliefARG NIT, AUR MET, AVENA, GELSEMIUM, HYOSCYAMUS, IGNATIA, MOSCHUS, NAT MUR, PASSIFLORA, STANNUM MET, VALERIANA.OHM PHARMA INC.b736ec93-199a-4d19-882a-186c0e2adb112021-12-29WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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