Simlandi 80 MG per 0.8 ML Auto-Injector

RxCUI: 2706645
RxNorm name: Simlandi 80 MG per 0.8 ML Auto-Injector
Display name: Simlandi 80 MG per 0.8 ML Auto-Injector
Full name: Simlandi 80 MG per 0.8 ML Auto-Injector
Term type: SY
Status: DailyMed mapping
Updated: 2026-06-04 23:38:48

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761299	Simlandi	adalimumab-ryvk	351(k) Interchangeable	Rx	2026-06-01

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simlandi	ADALIMUMAB-RYVK	Teva Pharmaceuticals USA, Inc.	12f609c9-2088-bb05-e063-6394a90a9ecc	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2706645

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
12f609c9-2088-bb05-e063-6394a90a9ecc	Simlandi 80 MG per 0.8 ML Auto-Injector	SY	24	These 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
12f609c9-2088-bb05-e063-6394a90a9ecc	Simlandi 80 MG in 0.8 ML Auto-Injector	PSN	24	These 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
12f609c9-2088-bb05-e063-6394a90a9ecc	0.8 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]	SBD	24	These 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
12f609c9-2088-bb05-e063-6394a90a9ecc	0.8 ML Simlandi 100 MG/ML Auto-Injector	SY	24	These 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