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 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
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 2026-07-01
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