FDA.reportPublic FDA data

NDC 61314-454-96 - HYRIMOZ

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
61314-454
Requested NDC
61314-454-96
Package NDCs from labels
61314-454-20, 61314-454-36, 61314-454-68, 61314-454-96, 61314-454-94
Manufacturer
Sandoz Inc
Effective date
2025-10-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYRIMOZ - Sandoz IncSandoz Inc2025-10-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-454-20HYRIMOZ0.8 mL in 1 SYRINGEINJECTION, SOLUTION0.813
61314-454-20HYRIMOZ2 in 1 CARTONINJECTION, SOLUTION213
61314-454-36HYRIMOZ3 in 1 CARTONINJECTION, SOLUTION313
61314-454-36HYRIMOZ0.8 mL in 1 SYRINGEINJECTION, SOLUTION0.813
61314-454-68HYRIMOZ0.8 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.813
61314-454-68HYRIMOZ3 in 1 CARTONINJECTION, SOLUTION313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-454HYRIMOZ (ADALIMUMAB-ADAZ) INJECTION, SOLUTION HYRIMOZ (ADALIMUMAB-ADAZ) KIT [SANDOZ INC]7Current NDC, 6 package rows20240426_1ac7d061-3380-468c-b077-c05f8dfbc829.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-454-20ML - Milliliter61314-454bfacbf5a-4eae-4d97-8f02-fe0e38b7722b12023-09-05
61314-454-36ML - Milliliter61314-454fa39df8a-8fc3-4922-bc72-b128b0f89c8f12023-09-05
61314-454-68ML - Milliliter61314-45448b68d36-723a-4597-bb57-b0fc2240163712023-09-05

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 5 of 12 · 224 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AdalimumabADALIMUMAB-ADAZSandoz Inc3468792f-63ef-4916-8ed1-8214f327d9dd2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761071
rxcui: 2641662
rxcui: 2641644
rxcui: 2641660
rxcui: 2641653
rxcui: 2641655
unii: FYS6T7F842
HYRIMOZADALIMUMAB-ADAZCordavis Limited3e303a4a-980b-4f2a-9d03-7869287586372025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761071
rxcui: 2641670
rxcui: 2641661
rxcui: 2641662
rxcui: 2641654
rxcui: 2641665
rxcui: 2641664
rxcui: 2641671
rxcui: 2641660
rxcui: 2641663
rxcui: 2641658
rxcui: 2641653
rxcui: 2641655
unii: FYS6T7F842
HYRIMOZADALIMUMAB-ADAZSandoz Inc1ac7d061-3380-468c-b077-c05f8dfbc8292025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761071
ndc (package): 61314-473-94
ndc (package): 61314-476-64
ndc (package): 61314-531-64
ndc (package): 61314-473-96
ndc (package): 61314-454-20
ndc (package): 61314-517-36
ndc (package): 61314-454-94
ndc (package): 61314-473-92
ndc (package): 61314-454-36
ndc (package): 61314-454-96
ndc (package): 61314-473-64
ndc (package): 61314-473-20
ndc (package): 61314-454-68
ndc (package): 61314-509-64
ndc (product): 61314-473
ndc (product): 61314-454
ndc (product): 61314-509
ndc (product): 61314-531
ndc (product): 61314-517
ndc (product): 61314-476
ndc11 (package): 61314045496
rxcui: 2641668
rxcui: 2641670
rxcui: 2641661
rxcui: 2641673
rxcui: 2641662
rxcui: 2641672
rxcui: 2641666
rxcui: 2641654
rxcui: 2641644
rxcui: 2641665
rxcui: 2641669
rxcui: 2641664
rxcui: 2641671
rxcui: 2641660
rxcui: 2641663
rxcui: 2641658
rxcui: 2641667
rxcui: 2641653
rxcui: 2641655
rxcui: 2641650
spl id: 48b7e44a-945f-487d-b2fd-3da13d6d6fdb
spl set id: 1ac7d061-3380-468c-b077-c05f8dfbc829
unii: FYS6T7F842
Adalimumab-bwwdADALIMUMAB-BWWDCordavis Limitedc24655e5-796e-4127-b716-92f08d649c832025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
YUSIMRYADALIMUMAB-AQVHCoherus BioSciences Inccd0e7af2-7704-49ce-bde9-f645294b67882025-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842

Reported adverse events (FAERS/openFDA)#

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