HADLIMA

Product NDC
50090-6707
11-digit product format
500906707
Labeler code
50090
Product ID
50090-6707_6ac2e906-b32e-4c8e-909f-ff26b987d0c3
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/.4mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HADLIMA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADALIMUMAB40 mg/.4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFYS6T7F842
Rxcui2640430, 2640432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6707-0HADLIMA2 in 1 CARTONSOLUTION23
50090-6707-0HADLIMA.4 mL in 1 SYRINGESOLUTION.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6707HADLIMA (ADALIMUMAB-BWWD) SOLUTION [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20231003_c361dd60-c88d-4f3c-b98c-79687bbc3450.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640430adalimumab-bwwd 40 MG in 0.4 ML Auto-InjectorPSNc361dd60-c88d-4f3c-b98c-79687bbc34503
2640432HADLIMA 40 MG in 0.4 ML Auto-InjectorPSNc361dd60-c88d-4f3c-b98c-79687bbc34503
26404320.4 ML adalimumab-bwwd 100 MG/ML Auto-Injector [Hadlima]SBDc361dd60-c88d-4f3c-b98c-79687bbc34503
26404300.4 ML adalimumab-bwwd 100 MG/ML Auto-InjectorSCDc361dd60-c88d-4f3c-b98c-79687bbc34503
26404320.4 ML Hadlima 100 MG/ML Auto-InjectorSYc361dd60-c88d-4f3c-b98c-79687bbc34503
2640430adalimumab-bwwd 40 MG per 0.4 ML Auto-InjectorSYc361dd60-c88d-4f3c-b98c-79687bbc34503
2640432Hadlima 40 MG per 0.4 ML Auto-InjectorSYc361dd60-c88d-4f3c-b98c-79687bbc34503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6707-0500906707002 SYRINGE in 1 CARTON (50090-6707-0) / .4 mL in 1 SYRINGE2 syringe2023-09-27NoNoCurrent