FDA.reportPublic FDA data

NDC 0944-2722 - 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
0944-2722
Package NDCs from labels
0944-2722-03
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
0944-2722-03HYQVIA5 mL in 1 VIAL, GLASSSOLUTION5 mL160 [USP'U] in 1mL22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-2722HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]19Unmatched20241120_7ca2c26f-4be2-48cd-be5b-486e350654ba.zip
0944-2722HYQVIA (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 28 of 46 · 914 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: 451W47IQ8X
Calcium Chloride DihydrateCALCIUM CHLORIDE DIHYDRATESomerset Therapeutics, LLC8f22eef7-cb4b-41c9-9fe4-7010aadf21642024-12-19Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
unii: 451W47IQ8X
Walgreens Saline Mist Extra StrengthSODIUM CHLORIDEWalgreen's Corporation90cbe2dc-36b6-77fb-e053-2995a90a28972024-12-18WarningsExact identifier
unii: 451W47IQ8X
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy6f1fe980-ca09-401d-aed6-d3d3387cc49a2024-12-18WarningsExact identifier
unii: 451W47IQ8X
Mast Cell ProHYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,Energique, Inc.5cd31e1d-0312-48d1-9ecd-d01c6fe3b6722024-12-11WarningsExact identifier
unii: 451W47IQ8X
Junior MovesANACARDIUM, BRYONIA, MAG MUR, NAT MUR, PLUMB METSilver Star Brands822d5481-7854-3fe7-e053-2a91aa0abf552024-12-03WarningsExact identifier
unii: 451W47IQ8X
Migo-EaseACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLASilver Star Brands816837f5-4487-657d-e053-2991aa0a78f42024-12-03WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company464c2d78-5c88-4668-a039-56dd3c1c9b202024-12-03Exact identifier
unii: 451W47IQ8X
XX Health ProLACHESIS, NAT MUR, PULSATILLA, SEPIA, SULPHURSilver Star Brands4d11a65e-696a-0727-e054-00144ff88e882024-12-02WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d4ddaf-9c07-a7fc-e063-6394a90adc0b2024-11-26WarningsExact identifier
unii: 451W47IQ8X
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
unii: 451W47IQ8X
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company99a15716-bbb9-4e33-a48d-20c58b81f3922024-11-13Exact identifier
unii: 451W47IQ8X
Itch FormulaANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENSDeseret Biologicals, Inc.4dfb177b-bff3-4b6d-8fd9-cadd1df7812c2024-11-12WarningsExact identifier
unii: 451W47IQ8X
HYLENEX RecombinantHYALURONIDASEAntares Pharma, Inc.3023cc56-ed4b-4e87-b3a1-81b20943f6582024-11-11Warnings, Adverse reactionsExact identifier
unii: 743QUY4VD8
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
unii: 451W47IQ8X
Calcium ChlorideCALCIUM CHLORIDECivica, Inc.7fa5d8e8-0610-4892-907e-5ef630a56e762024-11-08Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYd3f90d2f-4536-4d32-800b-7a798f8a35db2024-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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