FDA.reportPublic FDA data

0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]

RxCUI
2677787
RxNorm name
0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]
Display name
0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]
Full name
0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761299Simlandiadalimumab-ryvk351(k) InterchangeableRx2026-07-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimlandiADALIMUMAB-RYVKTeva Pharmaceuticals USA, Inc.12f609c9-2088-bb05-e063-6394a90a9ecc2025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2677787
SimlandiADALIMUMAB-RYVKA-S Medication Solutionsba9dd71c-13c9-4cfe-84a2-b4f17d1c583f2025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2677787

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
12f609c9-2088-bb05-e063-6394a90a9eccSimlandi 40 MG in 0.4 ML Auto-Injector [PSN] · 0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi] [SBD] · Simlandi 40 MG per 0.4 ML Auto-Injector [SY]324These highlights do not include all the information needed to use SIMLANDI safely and effectively. See full prescribing information for SIMLANDI. SIMLANDI ® (adalimumab-ryvk) injection, for subcutaneous use Initial U.S. Approval: 2024 SIMLANDI (adalimumab-ryvk) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences 20251222
ba9dd71c-13c9-4cfe-84a2-b4f17d1c583fSimlandi 40 MG in 0.4 ML Auto-Injector [PSN] · 0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi] [SBD] · Simlandi 40 MG per 0.4 ML Auto-Injector [SY]31These highlights do not include all the information needed to use SIMLANDI safely and effectively. See full prescribing information for SIMLANDI. SIMLANDI ® (adalimumab-ryvk) injection, for subcutaneous use Initial U.S. Approval: 2024 SIMLANDI (adalimumab-ryvk) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences 20251016