FDA.reportPublic FDA data

NDC 50474-350-01 - KYGEVVI

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
50474-350
Requested NDC
50474-350-01
Package NDCs from labels
50474-350-01, 50474-350-30
Manufacturer
UCB, Inc.
Effective date
2025-11-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
KYGEVVI - UCB, Inc.UCB, Inc.2025-11-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50474-350-01KYGEVVI1 in 1 PACKETPOWDER, FOR SOLUTION13
50474-350-30KYGEVVI30 in 1 CARTONPOWDER, FOR SOLUTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50474-350-01EA - Each50474-3508ff39ff9-fbd6-497f-89bc-fafc4aba21f412026-04-20
50474-350-30EA - Each50474-35086021315-33c0-483d-8be2-58583754451812025-12-16

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
KYGEVVIDOXECITINE AND DOXRIBTIMINEUCB, Inc.7d5ce670-9314-4fd7-8b0a-1447910dcf9e2025-11-10Warnings, Adverse reactionsExact identifier
application number: NDA219792
ndc (package): 50474-350-01
ndc (package): 50474-350-30
ndc (product): 50474-350
ndc11 (package): 50474035001
rxcui: 2737535
rxcui: 2737541
spl id: 433f8057-35f8-f7e8-e063-6294a90a3ffd
spl set id: 7d5ce670-9314-4fd7-8b0a-1447910dcf9e
unii: VC2W18DGKR
unii: 0W860991D6

Reported adverse events (FAERS/openFDA)#

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