FDA.reportPublic FDA data

NDC 76179-010-03 - QIVIGY kthm

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
76179-010
Requested NDC
76179-010-03
Package NDCs from labels
76179-010-01, 76179-010-02, 76179-010-03, 76179-010-04
Manufacturer
Kedrion S.p.A.
Effective date
2026-05-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
QIVIGY kthm - Kedrion S.p.A.Kedrion S.p.A.2026-05-26HUMAN PRESCRIPTION DRUG LABEL

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 ยท 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): 76179-010-02
ndc (package): 76179-010-01
ndc (package): 76179-010-04
ndc (package): 76179-010-03
ndc (product): 76179-010
ndc11 (package): 76179001003
rxcui: 2726025
rxcui: 2726026
rxcui: 2726016
rxcui: 2726023
spl id: 59a061e8-a6b0-4036-800e-1344e2d4ce97
spl set id: 6f1933e0-240f-48f4-b246-8a30e63a4160
unii: 66Y330CJHS

Reported adverse events (FAERS/openFDA)#

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