Simlandi

Product NDC: 50090-7718
11-digit product format: 500907718
Labeler code: 50090
Product ID: 50090-7718_ffe54a1c-8140-4302-9fed-17fec30cad7b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: adalimumab-ryvk
Dosage form: KIT
Route: SUBCUTANEOUS
Labeler: A-S Medication Solutions
Application: BLA761299
Marketing category: BLA
Marketing start: 2024-05-20
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Simlandi
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
797544	Internal RxNorm lookup
2677780	Internal RxNorm lookup
2677787	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58819a18-327d-463b-9e5e-26cc1dd9870d	Product name	1	20230313
c1c5a070-0e2e-43dd-af9c-a21585200342	Product name	1	20230104
2a463079-cd68-4798-a3d6-55c4c8578d57	Product name	1	20220728
652f8f6b-479d-477c-848a-374d5b0145b7	Product name	2	20151203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7718-0	Simlandi	1 in 1 KIT	KIT	1		1
50090-7718-0	Simlandi	24 in 1 CASE	KIT	24		1
51759-513-21	Simlandi	0.4 mL in 1 SYRINGE	INJECTION, SOLUTION	0.4 mL	40 mg in 0.4mL	1
65517-0002-1	Simlandi	0.4 mL in 1 POUCH	SWAB	0.4 mL	0.7 mL in 1mL	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7718-0	EA - Each	50090-7718	0f38020e-b29f-42ea-a51f-b74c994bf540	1	2026-01-08

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adalimumab-ryvk	ADALIMUMAB-RYVK	Teva Pharmaceuticals USA, Inc.	f8c0d3c2-b5ed-4bb8-927c-5c5529343ee6	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761299
Adalimumab-ryvk	ADALIMUMAB-RYVK	Quallent Pharmaceuticals Health LLC	dce1590f-9e47-4c4d-9437-cfb18b779a75	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761299
Adalimumab-ryvk	ADALIMUMAB-RYVK	Teva Pharmaceuticals USA, Inc.	2d19a877-1f5a-4731-800a-dddadc424080	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761299
Simlandi	ADALIMUMAB-RYVK	Teva Pharmaceuticals USA, Inc.	12f609c9-2088-bb05-e063-6394a90a9ecc	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761299
Simlandi	ADALIMUMAB-RYVK	A-S Medication Solutions	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761299 ndc (product): 50090-7718

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	2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2677780	adalimumab-ryvk 40 MG in 0.4 ML Auto-Injector	PSN	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	1
797544	isopropyl alcohol 70 % Medicated Pad	PSN	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	1
2677787	Simlandi 40 MG in 0.4 ML Auto-Injector	PSN	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	1
2677787	0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector [Simlandi]	SBD	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	1
2677780	0.4 ML adalimumab-ryvk 100 MG/ML Auto-Injector	SCD	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	1
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	1
2677780	adalimumab-ryvk 40 MG per 0.4 ML Auto-Injector	SY	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	1
797544	isopropyl alcohol 70 % Medicated Pad	SY	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	1
797544	isopropyl alcohol 70 % Topical Cloth	SY	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	1
797544	isopropyl alcohol 70 % Topical Swab	SY	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	1
2677787	Simlandi 40 MG per 0.4 ML Auto-Injector	SY	ba9dd71c-13c9-4cfe-84a2-b4f17d1c583f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7718-0	50090771800	24 KIT in 1 CASE (50090-7718-0) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE (51759-513-21) * .4 mL in 1 POUCH (65517-0002-1)	24 kit	2025-10-16	No	No	Current
51759-513-21	51759051321	0.4 mL in 1 SYRINGE	0.4 ml				Historical
65517-0002-1	65517000201	0.4 mL in 1 POUCH	0.4 ml				Historical