FDA.reportPublic FDA data

QIVIGY

Product NDC
76179-010
Requested package NDC
76179-010-04
11-digit product format
761790010
Labeler code
76179
Product ID
76179-010_59a061e8-a6b0-4036-800e-1344e2d4ce97
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 g/50mL
Pharmacologic classes
Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
QIVIGY
Brand name suffix
kthm
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
66Y330CJHSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2726016Internal RxNorm lookup
2726023Internal RxNorm lookup
2726025Internal RxNorm lookup
2726026Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6f1933e0-240f-48f4-b246-8a30e63a4160Available on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QIVIGY kthmHUMAN IMMUNOGLOBULIN GKedrion S.p.A.6f1933e0-240f-48f4-b246-8a30e63a41602026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125822
ndc (package): 76179-010-04
ndc (product): 76179-010
ndc11 (package): 76179001004

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125822QIVIGYImmune Globulin Intravenous, Human-kthm, 10% Solution351(a)Rx2026-09-01

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 formatDescriptionMarketing startSampleExclude flagStatus
76179-010-04761790010041 VIAL, GLASS in 1 CARTON (76179-010-04) / 100 mL in 1 VIAL, GLASS (76179-010-03) 2025-09-26NoNoCurrent