FDA.reportPublic FDA data

NDC 0944-2716 - HYQVIA

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
0944-2716
Package NDCs from labels
0944-2716-05
Manufacturer
Takeda Pharmaceuticals America, Inc. | Baxalta Belgium Manufacturing SA | Catalent Indiana, LLC | Takeda Manufacturing Austria AG | Baxalta US Inc.
Effective date
2026-06-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYQVIATakeda Pharmaceuticals America, Inc. | Baxalta Belgium Manufacturing SA | Catalent Indiana, LLC | Takeda Manufacturing Austria AG | Baxalta US Inc.2026-06-18PLASMA DERIVATIVE
HYQVIA - Bamboo US BidCo LLCBamboo US BidCo LLC2024-12-17PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-2716-05HYQVIA50 mL in 1 VIAL, GLASSSOLUTION50 mL100 mg in 1mL22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-2716HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]19Unmatched20241120_7ca2c26f-4be2-48cd-be5b-486e350654ba.zip
0944-2716HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN IMMUNOGLOBULIN GACTIVE INGREDIENT66Y330CJHSHYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT [BAXTER HEALTHCARE CORPORATION]1
HYALURONIDASE (HUMAN RECOMBINANT)ACTIVE INGREDIENT743QUY4VD8HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT [BAXTER HEALTHCARE CORPORATION]1
HUMAN IMMUNOGLOBULIN GACTIVE MOIETY66Y330CJHSHYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT [BAXTER HEALTHCARE CORPORATION]1
HYALURONIDASE (HUMAN RECOMBINANT)ACTIVE MOIETY743QUY4VD8HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT [BAXTER HEALTHCARE CORPORATION]1
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRHYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT [BAXTER HEALTHCARE CORPORATION]1
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MHYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT [BAXTER HEALTHCARE CORPORATION]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT [BAXTER HEALTHCARE CORPORATION]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CHYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT [BAXTER HEALTHCARE CORPORATION]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT [BAXTER HEALTHCARE CORPORATION]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT [BAXTER HEALTHCARE CORPORATION]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT HYQVIA (HUMAN IMMUNEGLOBULIN G AND HYALURONIDASE (HUMAN RECOMBINANT)) KIT [BAXTER HEALTHCARE CORPORATION]1

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 5 of 46 · 914 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X
AKSO N2 Youth Complex EssenceARGININE PYROGLUTAMATE, COLEUS FORSKOHLII, GLUTAMINE, GLYCINE, MUCUNA PRURIENS, ORNITHINE ALPHA-KETOGLUTARATE, DIOSCOREA VILLOSA, TYROSINEHEALWAY5028304b-22b4-c191-e063-6394a90a55252026-04-23WarningsExact identifier
unii: TE7660XO1C
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Cardioforce IIABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNISBioActive Nutritional, Inc.733bbb26-7698-4a1b-9dc8-7e3490ffc92b2026-04-17WarningsExact identifier
unii: 451W47IQ8X
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS)BioActive Nutritional, Inc.3795820a-cf2a-4094-9a02-70e3757b75102026-04-17WarningsExact identifier
unii: 451W47IQ8X
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC99c6a1a9-cadf-435b-a332-ccc189afdfa92026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Anxiety ReliefACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUMNaturalCare9f982e89-655c-49be-85d8-4099a02ed0212026-04-15WarningsExact identifier
unii: 451W47IQ8X
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
unii: 451W47IQ8X
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: 451W47IQ8X
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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