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 22 of 46 · 914 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BIO16 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products3036922b-0f2c-12ff-e063-6394a90a85782025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20 Lactose FreeCALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products30394e7e-170f-7b9d-e063-6394a90afcdb2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO27 Lactose FreeNAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products303b25cc-b559-3841-e063-6294a90a398b2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28 Lactose FreeCALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products303b4d92-9f75-38a5-e063-6294a90ae93d2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, CROTON TIGLIUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.6a12aa49-35fc-41f4-bec8-6f9a20a97caa2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO4 Lactose FreeCALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products30220aca-e052-95f3-e063-6294a90a9cea2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5 Lactose FreeFERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products30225814-b9d7-f16a-e063-6294a90a01942025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6 Lactose FreeFERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products302292bd-9c38-2638-e063-6294a90a965d2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11 Lactose FreeFERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products3025f91f-bc0a-691c-e063-6294a90ad1362025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12 Lactose FreeFERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products30262ecd-5bd9-80d0-e063-6294a90ab1db2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20CALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products300d4674-5c2e-01b6-e063-6294a90acbf92025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO27NAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products300e8ba5-1b16-ad40-e063-6294a90a674d2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products300ead4c-6937-d597-e063-6394a90ad6bb2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO1 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products3013926f-ecd2-d376-e063-6294a90a47432025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO2 Lactose FreeKALI PHOS, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products3013d3a9-7f20-4d19-e063-6394a90a58142025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products2ffcffd8-94ba-3a4c-e063-6394a90a24ee2025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products2ffd4d8f-75bf-1b9b-e063-6294a90abc362025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products2ffd93dd-1084-4b24-e063-6294a90a14332025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11FERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products2fff2361-a171-2249-e063-6394a90a8b652025-03-10WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12FERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products2fff612e-16dc-dcbf-e063-6294a90a22ad2025-03-10WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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