Home NDC 82009-148 Adalimumab-adbm
Product NDC 82009-148
11-digit product format 820090148
Labeler code 82009
Product ID 82009-148_64b7451d-b06d-486b-9b34-a55001711063
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Adalimumab-adbm
Dosage form KIT
Labeler QUALLENT PHARMACEUTICALS HEALTH LLC
Application BLA761058
Marketing category BLA
Marketing start 2024-04-30
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Adalimumab-adbm
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797544 Internal RxNorm lookup 2640883 Internal RxNorm lookup 2640895 Internal RxNorm lookup 2680743 Internal RxNorm lookup 2680748 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 82009-148-22 Adalimumab-adbm 2 in 1 CARTON KIT 2 3 82009-148-22 Adalimumab-adbm 1 in 1 KIT KIT 1 3 82009-149-11 Adalimumab-adbm 0.8 mL in 1 SYRINGE INJECTION, SOLUTION 0.8 mL 40 mg in 0.8mL 3 82009-149-11 Adalimumab-adbm 1 in 1 TRAY INJECTION, SOLUTION 40 mg in 0.8mL 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82009-148 ADALIMUMAB-ADBM KIT [QUALLENT PHARMACEUTICALS HEALTH LLC] 1 Current NDC, 4 package rows 20240508_f9986706-9c75-4335-a54f-09d7716dbcef.zip
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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cyltezo ADALIMUMAB-ADBM Boehringer Ingelheim Pharmaceuticals, Inc. 115ea79b-7209-7f19-b35d-36ec0828fbf5 2026-05-22 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761058 Adalimumab-adbm ADALIMUMAB-ADBM Boehringer Ingelheim Pharmaceuticals, Inc. 62f39a7c-00df-4519-a8d4-39bbd0a649ed 2025-11-12 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761058 Adalimumab-adbm ADALIMUMAB-ADBM QUALLENT PHARMACEUTICALS HEALTH LLC f9986706-9c75-4335-a54f-09d7716dbcef 2024-11-12 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761058 ndc (product): 82009-148
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761058 Cyltezo adalimumab-adbm 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 82009-148-22 82009014822 2 KIT in 1 CARTON (82009-148-22) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (82009-149-11) / .8 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET 2 kit 2024-04-30 No No Current 82009-149-11 82009014911 0.8 mL in 1 SYRINGE 0.8 ml Historical