Home NDC 50090-6705 HADLIMA
Product NDC 50090-6705
11-digit product format 500906705
Labeler code 50090
Product ID 50090-6705_f29c7432-aeb1-4eea-b6b1-05572b973220
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name adalimumab-bwwd
Dosage form SOLUTION
Route SUBCUTANEOUS
Labeler A-S Medication Solutions
Application BLA761059
Marketing category BLA
Marketing start 2023-07-01
Substance ADALIMUMAB
Active strength 40 mg/.8mL
Pharmacologic classes Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base HADLIMA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ADALIMUMAB 40 mg/.8mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FYS6T7F842 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2640302 Internal RxNorm lookup 2640305 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 50090-6705-0 HADLIMA 1 in 1 CARTON SOLUTION 1 3 50090-6705-0 HADLIMA .8 mL in 1 SYRINGE SOLUTION .8 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6705 HADLIMA (ADALIMUMAB-BWWD) SOLUTION [A-S MEDICATION SOLUTIONS] 3 Current NDC, 2 package rows 20231102_7345f276-102e-4175-b7ef-ff1706b05472.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HADLIMA ADALIMUMAB-BWWD A-S Medication Solutions c361dd60-c88d-4f3c-b98c-79687bbc3450 2026-05-14 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761059 Adalimumab-bwwd ADALIMUMAB-BWWD Cordavis Limited c24655e5-796e-4127-b716-92f08d649c83 2025-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761059 HADLIMA ADALIMUMAB-BWWD A-S Medication Solutions 7345f276-102e-4175-b7ef-ff1706b05472 2023-10-23 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761059 ndc (product): 50090-6705 HADLIMA ADALIMUMAB-BWWD A-S Medication Solutions ef25af7e-6267-409a-8d68-de51eb48812a 2023-10-02 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761059
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761059 Hadlima adalimumab-bwwd 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 50090-6705-0 50090670500 1 SYRINGE in 1 CARTON (50090-6705-0) / .8 mL in 1 SYRINGE 1 syringe 2023-09-27 No No Current