FDA.reportPublic FDA data

HYQVIA

Product NDC
0944-2511
11-digit product format
009442511
Labeler code
0944
Product ID
0944-2511_2233ffe2-ff7d-44b6-b95b-fb985e25c758
Type
PLASMA DERIVATIVE
Nonproprietary name
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase
Dosage form
KIT
Labeler
Takeda Pharmaceuticals America, Inc.
Application
BLA125402
Marketing category
BLA
Marketing start
2014-09-12
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYQVIA
Listing expiration
2027-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fba5a780-b52d-4964-b662-1526b044aec4Product name120260127
64196b0b-840e-435b-8afa-0b0e9d9cea99Product name120251024
4b151d8d-9b47-43df-bccb-6abc1c4e7194Product name120250331
d745a796-f789-46a3-afa3-79dead22a863Product name120250331
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
00bb4496-246c-4f2c-910a-2b2783035958Product name120231025
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
0c6eff6a-9a1e-468b-b9ca-6bc864c2e8cbProduct name120200925
6d78c268-2e9d-bd45-9f2d-965fd0e582caProduct name220200323
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
4597a7a9-59c8-4eb4-b516-4f26fa3dfe4bProduct name120170804
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-2511-02HYQVIA1 in 1 CARTONKIT122
0944-2716-05HYQVIA50 mL in 1 VIAL, GLASSSOLUTION50 mL100 mg in 1mL22
0944-2721-03HYQVIA2.5 mL in 1 VIAL, GLASSSOLUTION2.5 mL160 [USP'U] in 1mL22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0944-2511-02ML - Milliliter0944-2511a4f5ea5b-1649-4d4d-a02b-ae4336707c4612014-10-03

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-2511HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]19Current NDC, Legacy NDC, 3 package rows20241120_7ca2c26f-4be2-48cd-be5b-486e350654ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549690{1 (1.25 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (25 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 2.5 G / 25 ML Kit]BPCK7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549696{1 (10 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (200 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 20 G / 200 ML Kit]BPCK7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549694{1 (100 ML immunoglobulin G, human 100 MG/ML Injection) / 1 (5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) } Pack [Hyqvia 10 G / 100 ML Kit]BPCK7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549688{1 (15 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (300 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 30 G / 300 ML Kit]BPCK7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549692{1 (2.5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (50 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 5 G / 50 ML Kit]BPCK7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549689{1 (1.25 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (25 ML immunoglobulin G, human 100 MG/ML Injection) } PackGPCK7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549695{1 (10 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (200 ML immunoglobulin G, human 100 MG/ML Injection) } PackGPCK7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549693{1 (100 ML immunoglobulin G, human 100 MG/ML Injection) / 1 (5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) } PackGPCK7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549687{1 (15 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (300 ML immunoglobulin G, human 100 MG/ML Injection) } PackGPCK7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549691{1 (2.5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (50 ML immunoglobulin G, human 100 MG/ML Injection) } PackGPCK7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809535hyaluronidase, human recombinant 1600 UNT in 10 ML InjectionPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809531hyaluronidase, human recombinant 200 UNT in 1.25 ML InjectionPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809538hyaluronidase, human recombinant 2400 UNT in 15 ML InjectionPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809542hyaluronidase, human recombinant 400 UNT in 2.5 ML InjectionPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809545hyaluronidase, human recombinant 800 UNT in 5 ML InjectionPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549694HYQVIA 10 GM / 100 ML KitPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549690HYQVIA 2.5 GM / 25 ML KitPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549696HYQVIA 20 GM / 200 ML KitPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549688HYQVIA 30 GM / 300 ML KitPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549692HYQVIA 5 GM / 50 ML KitPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809421immunoglobulin G, human 10 % in 100 ML InjectionPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809444immunoglobulin G, human 10 % in 200 ML InjectionPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809438immunoglobulin G, human 10 % in 25 ML InjectionPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809539immunoglobulin G, human 10 % in 300 ML InjectionPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809414immunoglobulin G, human 10 % in 50 ML InjectionPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549693immunoglobulin G, human 10 GM / hyaluronidase, human recombinant 800 UNT KitPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549689immunoglobulin G, human 2.5 GM / hyaluronidase, human recombinant 200 UNT KitPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549695immunoglobulin G, human 20 GM / hyaluronidase, human recombinant 1600 UNT KitPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549687immunoglobulin G, human 30 GM / hyaluronidase, human recombinant 2400 UNT KitPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549691immunoglobulin G, human 5 GM / hyaluronidase, human recombinant 400 UNT KitPSN7ca2c26f-4be2-48cd-be5b-486e350654ba22
18095311.25 ML hyaluronidase, human recombinant 160 UNT/ML InjectionSCD7ca2c26f-4be2-48cd-be5b-486e350654ba22
180953510 ML hyaluronidase, human recombinant 160 UNT/ML InjectionSCD7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809421100 ML immunoglobulin G, human 100 MG/ML InjectionSCD7ca2c26f-4be2-48cd-be5b-486e350654ba22
180953815 ML hyaluronidase, human recombinant 160 UNT/ML InjectionSCD7ca2c26f-4be2-48cd-be5b-486e350654ba22
18095422.5 ML hyaluronidase, human recombinant 160 UNT/ML InjectionSCD7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809444200 ML immunoglobulin G, human 100 MG/ML InjectionSCD7ca2c26f-4be2-48cd-be5b-486e350654ba22
180943825 ML immunoglobulin G, human 100 MG/ML InjectionSCD7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809539300 ML immunoglobulin G, human 100 MG/ML InjectionSCD7ca2c26f-4be2-48cd-be5b-486e350654ba22
18095455 ML hyaluronidase, human recombinant 160 UNT/ML InjectionSCD7ca2c26f-4be2-48cd-be5b-486e350654ba22
180941450 ML immunoglobulin G, human 100 MG/ML InjectionSCD7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809535hyaluronidase, human recombinant 1600 UNT per 10 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809531hyaluronidase, human recombinant 200 UNT per 1.25 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809538hyaluronidase, human recombinant 2400 UNT per 15 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809542hyaluronidase, human recombinant 400 UNT per 2.5 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809545hyaluronidase, human recombinant 800 UNT per 5 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549696Hyqvia 1600 UNT per 10 ML / 20 G per 200 ML (10 % ) KitSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549690Hyqvia 200 UNT per 1.25 ML / 2.5 G per 25 ML (10 % ) KitSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549688Hyqvia 2400 UNT per 15 ML / 30 G per 300 ML (10 % ) KitSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549692Hyqvia 400 UNT per 2.5 ML / 5 G per 50 ML (10 % ) KitSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549694Hyqvia 800 UNT per 5 ML / 10 G per 100 ML (10 % ) KitSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809421immunoglobulin G, human 10 % per 100 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809444immunoglobulin G, human 10 % per 200 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809438immunoglobulin G, human 10 % per 25 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809539immunoglobulin G, human 10 % per 300 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809414immunoglobulin G, human 10 % per 50 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809421immunoglobulin G, human 10 GM per 100 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809438immunoglobulin G, human 2.5 GM per 25 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809444immunoglobulin G, human 20 GM per 200 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1549687immunoglobulin G, human 30 GM / hyaluronidase, human recombinant 2400 UNT KitSY7ca2c26f-4be2-48cd-be5b-486e350654ba22
1809414immunoglobulin G, human 5 GM per 50 ML InjectionSY7ca2c26f-4be2-48cd-be5b-486e350654ba22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0944-2511-02009442511021 KIT in 1 CARTON (0944-2511-02) * 50 mL in 1 VIAL, GLASS (0944-2716-05) * 2.5 mL in 1 VIAL, GLASS (0944-2721-03) 1 kit2014-09-120000-00-00NoNoCurrent
0944-2716-050094427160550 mL in 1 VIAL, GLASS50 mlHistorical
0944-2721-03009442721032.5 mL in 1 VIAL, GLASS2.5 mlHistorical