FDA.reportPublic FDA data

QIVIGY

Product NDC
76179-010
11-digit product format
761790010
Labeler code
76179
Product ID
76179-010_41b0fa95-dac0-4df9-a315-c270de6a43c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
human immunoglobulin g
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Kedrion S.p.A.
Application
BLA125822
Marketing category
BLA
Marketing start
2025-09-26
Substance
HUMAN IMMUNOGLOBULIN G
Active strength
5 mg/50mL
Pharmacologic classes
Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
QIVIGY
Brand name suffix
kthm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G5 mg/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii66Y330CJHS
Rxcui2726016, 2726023, 2726025, 2726026

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76179-010-01QIVIGY kthm50 mL in 1 VIAL, GLASSINJECTION, SOLUTION504
76179-010-02QIVIGY kthm1 in 1 CARTONINJECTION, SOLUTION14
76179-010-03QIVIGY kthm100 mL in 1 VIAL, GLASSINJECTION, SOLUTION1004
76179-010-04QIVIGY kthm1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76179-010-01ML - Milliliter76179-010b0cc3b42-750c-42cd-af82-45537515055112026-03-17
76179-010-02ML - Milliliter76179-010192f8e3c-bd02-4682-b71b-d2162c14051e12026-03-17
76179-010-03ML - Milliliter76179-010698a17f0-3c09-45fe-8d05-3a723758919712026-03-17
76179-010-04ML - Milliliter76179-0105e767c34-d1ff-42db-8f33-6a59c8b9d0c712026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2726025immune globulin intravenous (human) - kthm 10 % in 100 ML InjectionPSN6f1933e0-240f-48f4-b246-8a30e63a41604
2726016immune globulin intravenous (human) - kthm 10 % in 50 ML InjectionPSN6f1933e0-240f-48f4-b246-8a30e63a41604
2726026Qivigy 10 % in 100 ML InjectionPSN6f1933e0-240f-48f4-b246-8a30e63a41604
2726023QIVIGY 10 % in 50 ML InjectionPSN6f1933e0-240f-48f4-b246-8a30e63a41604
2726026100 ML immune globulin intravenous (human) - kthm 100 MG/ML Injection [Qivigy]SBD6f1933e0-240f-48f4-b246-8a30e63a41604
272602350 ML immune globulin intravenous (human) - kthm 100 MG/ML Injection [Qivigy]SBD6f1933e0-240f-48f4-b246-8a30e63a41604
2726025100 ML immune globulin intravenous (human) - kthm 100 MG/ML InjectionSCD6f1933e0-240f-48f4-b246-8a30e63a41604
272601650 ML immune globulin intravenous (human) - kthm 100 MG/ML InjectionSCD6f1933e0-240f-48f4-b246-8a30e63a41604
2726026100 ML Qivigy 100 MG/ML InjectionSY6f1933e0-240f-48f4-b246-8a30e63a41604
272602350 ML Qivigy 100 MG/ML InjectionSY6f1933e0-240f-48f4-b246-8a30e63a41604
2726025immune globulin intravenous (human) - kthm 10 % per 100 ML InjectionSY6f1933e0-240f-48f4-b246-8a30e63a41604
2726016immune globulin intravenous (human) - kthm 10 % per 50 ML InjectionSY6f1933e0-240f-48f4-b246-8a30e63a41604
2726026Qivigy 10 % per 100 ML InjectionSY6f1933e0-240f-48f4-b246-8a30e63a41604
2726023Qivigy 10 % per 50 ML InjectionSY6f1933e0-240f-48f4-b246-8a30e63a41604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76179-010-017617900100150 mL in 1 VIAL, GLASS50 mlHistorical
76179-010-02761790010021 VIAL, GLASS in 1 CARTON (76179-010-02) / 50 mL in 1 VIAL, GLASS (76179-010-01) 2025-09-26NoNoHistorical
76179-010-0376179001003100 mL in 1 VIAL, GLASS100 mlHistorical
76179-010-04761790010041 VIAL, GLASS in 1 CARTON (76179-010-04) / 100 mL in 1 VIAL, GLASS (76179-010-03) 2025-09-26NoNoHistorical