Home NDC 82009-158 Adalimumab-ryvk
Product NDC 82009-158
11-digit product format 820090158
Labeler code 82009
Product ID 82009-158_e837767b-482a-487d-9d35-4516a8c25b3e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name adalimumab-ryvk
Dosage form KIT
Route SUBCUTANEOUS
Labeler Quallent Pharmaceuticals Health LLC
Application BLA761299
Marketing category BLA
Marketing start 2024-07-31
NDC exclude flag No
Listing certified through 2027-12-31
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 ndc (product): 82009-158 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
Additional Listing Data#
Finished product Yes
Brand name base Adalimumab-ryvk
Listing expiration 2027-12-31 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 2688826 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 82009-158-22 Adalimumab-ryvk 1 in 1 KIT KIT 1 12 82009-158-22 Adalimumab-ryvk 2 in 1 CARTON KIT 2 12 82009-159-11 Adalimumab-ryvk 0.4 mL in 1 SYRINGE INJECTION, SOLUTION 0.4 mL 40 mg in 0.4mL 12 82009-159-11 Adalimumab-ryvk 1 in 1 TRAY INJECTION, SOLUTION 40 mg in 0.4mL 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82009-158 ADALIMUMAB-RYVK KIT [QUALLENT PHARMACEUTICALS HEALTH LLC] 6 Current NDC, 4 package rows 20250326_dce1590f-9e47-4c4d-9437-cfb18b779a75.zip
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 82009-158-22 82009015822 2 KIT in 1 CARTON (82009-158-22) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (82009-159-11) / .4 mL in 1 SYRINGE * .4 mL in 1 POUCH 2 kit 2024-07-31 No No Current 82009-159-11 82009015911 0.4 mL in 1 SYRINGE 0.4 ml Historical