Home NDC 50090-7718 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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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.
DailyMed Product Concepts# 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
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
DailyMed RxNorm Mappings# 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