FDA.reportPublic FDA data

NDC 61434-005 - SB5 (BIIB606)

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
61434-005
Package NDCs from labels
61434-005-00
Manufacturer
Catalent Indiana, LLC
Effective date
2025-08-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SB5 (BIIB606) - Catalent Indiana, LLCCatalent Indiana, LLC2025-08-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61434-005-00SB5 (BIIB606)1280 in 1 CASEINJECTION, SOLUTION128012
61434-005-00SB5 (BIIB606)0.8 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61434-005SB5 (BIIB606) (ADALIMUMAB-BWWD) INJECTION, SOLUTION [CATALENT INDIANA, LLC]112 package rows20241104_002d3e04-7558-4e22-85bb-09e30566bd0b.zip

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 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMJEVITAADALIMUMAB-ATTOAmgen USA Inc.b7178e36-6787-45ab-8fee-be59bc6a4aa42026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
AMJEVITAADALIMUMAB-ATTOAmgen, Inc9c44bd5b-4464-40a4-8933-8680950f00f22026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
AMJEVITAADALIMUMAB-ATTONuvaila Limitedd7862491-2634-4402-b001-dcc1abf8dd582026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
HADLIMAADALIMUMAB-BWWDA-S Medication Solutionsc361dd60-c88d-4f3c-b98c-79687bbc34502026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
AdalimumabADALIMUMAB-ADAZSandoz Inc3468792f-63ef-4916-8ed1-8214f327d9dd2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
HYRIMOZADALIMUMAB-ADAZCordavis Limited3e303a4a-980b-4f2a-9d03-7869287586372025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
HYRIMOZADALIMUMAB-ADAZSandoz Inc1ac7d061-3380-468c-b077-c05f8dfbc8292025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
Adalimumab-bwwdADALIMUMAB-BWWDCordavis Limitedc24655e5-796e-4127-b716-92f08d649c832025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
3c425d08-4168-a5bc-e063-6394a90a2e95002d3e04-7558-4e22-85bb-09e30566bd0b2025-08-13Exact identifier
spl id: 3c425d08-4168-a5bc-e063-6394a90a2e95
spl set id: 002d3e04-7558-4e22-85bb-09e30566bd0b
YUSIMRYADALIMUMAB-AQVHCoherus BioSciences Inccd0e7af2-7704-49ce-bde9-f645294b67882025-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
HADLIMAADALIMUMAB-BWWDA-S Medication Solutions7345f276-102e-4175-b7ef-ff1706b054722023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842
HADLIMAADALIMUMAB-BWWDA-S Medication Solutionsef25af7e-6267-409a-8d68-de51eb48812a2023-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: FYS6T7F842

Reported adverse events (FAERS/openFDA)#

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