HADLIMA

Product NDC
50090-6706
11-digit product format
500906706
Labeler code
50090
Product ID
50090-6706_0b7601d5-a393-47fb-a71a-cfbe1ec2b153
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
IngredientStrength
ADALIMUMAB40 mg/.8mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFYS6T7F842
Rxcui2640287, 2640300

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6706-0HADLIMA1 mL in 1 CARTONSOLUTION11
50090-6706-0HADLIMA2 in 1 CARTONSOLUTION21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6706HADLIMA (ADALIMUMAB-BWWD) SOLUTION [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20231003_ef25af7e-6267-409a-8d68-de51eb48812a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640287adalimumab-bwwd 40 MG in 0.8 ML Auto-InjectorPSNef25af7e-6267-409a-8d68-de51eb48812a1
2640300HADLIMA 40 MG in 0.8 ML Auto-InjectorPSNef25af7e-6267-409a-8d68-de51eb48812a1
26403000.8 ML adalimumab-bwwd 50 MG/ML Auto-Injector [Hadlima]SBDef25af7e-6267-409a-8d68-de51eb48812a1
26402870.8 ML adalimumab-bwwd 50 MG/ML Auto-InjectorSCDef25af7e-6267-409a-8d68-de51eb48812a1
26403000.8 ML Hadlima 50 MG/ML Auto-InjectorSYef25af7e-6267-409a-8d68-de51eb48812a1
2640287adalimumab-bwwd 40 MG per 0.8 ML Auto-InjectorSYef25af7e-6267-409a-8d68-de51eb48812a1
2640300Hadlima 40 MG per 0.8 ML Auto-InjectorSYef25af7e-6267-409a-8d68-de51eb48812a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6706-0500906706002 CARTON in 1 CARTON (50090-6706-0) / 1 mL in 1 CARTON2 carton2023-09-27NoNoCurrent