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 15 of 46 · 914 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLISTER HPJUGLANS CINEREA BRANCH BARK/ROOT BARK, POTASSIUM IODIDE, LYCOPODIUM CLAVATUM SPORE, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG.Natural Creations, Inc.e76f05e7-6d7b-4d2e-ba26-bf776bf0e6572025-11-13WarningsExact identifier
unii: 451W47IQ8X
Anxiety HPARSENIC TRIOXIDE, CALCIUM CARBONATE, STRYCHNOS IGNATII SEED, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLANatural Creations, Inc.13d92246-c20e-47a8-b88f-22da876fc5452025-11-13WarningsExact identifier
unii: 451W47IQ8X
ANXIETY II HPACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, HUMAN BREAST TUMOR CELL, CAUSTICUM, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAFNatural Creations, Inc.02fa45a5-08e1-41ad-acd4-0f85db07e89e2025-11-13WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.af6aebad-ef03-4d19-9a40-18e5a278b8122025-11-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC27dbf0bf-c273-2108-e063-6394a90a0a092025-11-10WarningsExact identifier
unii: 451W47IQ8X
AZO Yeast PlusCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURi-Health, Inc.22845cac-8011-4ea8-b35e-b72973eddb442025-11-07WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHenry Schein, Inc.2e81ffca-05c6-4fa0-8911-4b3cbfa713512025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDERising Pharma Holdings, Inc.42870188-b1d7-4934-a6c0-310530497dac2025-11-07WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.d8b8d796-bfba-42af-a859-99d7768715582025-11-07Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.31188cdf-7bc8-4d78-bfaf-c1dc9f851fd42025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.d3d29c8f-c326-4097-814a-7f4e08c670682025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.01721071-af03-4894-95c1-10b8bc64b8882025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.f6d82772-638c-4584-b9d3-8833669f59632025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Com-Pare2 Dual Yeast Relief Plus Multi-symptom FormulaCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, SULPHURTRP Company42b6b9b9-a673-0bba-e063-6394a90a88662025-11-03WarningsExact identifier
unii: 451W47IQ8X
Aminosyn IIISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINEICU Medical Inc.5b426208-f090-4650-86c3-89040ba45c2d2025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEICU Medical Inc.d8ee14e9-6733-4813-9f21-2b043a5f71882025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEICU Medical Inc.4555b1bf-6d97-4798-a63d-6d34291c85ce2025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEICU Medical Inc.9dd1c001-73b3-41d4-9a96-61f6ad3a5dc32025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEICU Medical Inc.3cfdeee0-ff14-4341-8396-b11c2a037c602025-11-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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