FDA.reportPublic FDA data

Hadlima

Product NDC
78206-185
11-digit product format
782060185
Labeler code
78206
Product ID
78206-185_28a18c27-7052-4b4d-af4e-d81048f424e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-bwwd
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
Organon LLC
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
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/.8mL

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-185-01Hadlima1 in 1 CARTONSOLUTION113
78206-185-99Hadlima1 in 1 CARTONSOLUTION113
78206-185-99Hadlima0.8 mL in 1 VIALSOLUTION0.813

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-185HADLIMA (ADALIMUMAB-BWWD) SOLUTION [ORGANON LLC]10Current NDC, 3 package rows20240713_4774a951-3ce8-43b6-80b1-e6b23752aae6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640430adalimumab-bwwd 40 MG in 0.4 ML Auto-InjectorPSN4774a951-3ce8-43b6-80b1-e6b23752aae613
2640425adalimumab-bwwd 40 MG in 0.4 ML Prefilled SyringePSN4774a951-3ce8-43b6-80b1-e6b23752aae613
2640287adalimumab-bwwd 40 MG in 0.8 ML Auto-InjectorPSN4774a951-3ce8-43b6-80b1-e6b23752aae613
2640419adalimumab-bwwd 40 MG in 0.8 ML InjectionPSN4774a951-3ce8-43b6-80b1-e6b23752aae613
2640302adalimumab-bwwd 40 MG in 0.8 ML Prefilled SyringePSN4774a951-3ce8-43b6-80b1-e6b23752aae613
2640432HADLIMA 40 MG in 0.4 ML Auto-InjectorPSN4774a951-3ce8-43b6-80b1-e6b23752aae613
2640428HADLIMA 40 MG in 0.4 ML Prefilled SyringePSN4774a951-3ce8-43b6-80b1-e6b23752aae613
2640300HADLIMA 40 MG in 0.8 ML Auto-InjectorPSN4774a951-3ce8-43b6-80b1-e6b23752aae613
2640422HADLIMA 40 MG in 0.8 ML InjectionPSN4774a951-3ce8-43b6-80b1-e6b23752aae613
2640305HADLIMA 40 MG in 0.8 ML Prefilled SyringePSN4774a951-3ce8-43b6-80b1-e6b23752aae613
26404320.4 ML adalimumab-bwwd 100 MG/ML Auto-Injector [Hadlima]SBD4774a951-3ce8-43b6-80b1-e6b23752aae613
26404280.4 ML adalimumab-bwwd 100 MG/ML Prefilled Syringe [Hadlima]SBD4774a951-3ce8-43b6-80b1-e6b23752aae613
26403000.8 ML adalimumab-bwwd 50 MG/ML Auto-Injector [Hadlima]SBD4774a951-3ce8-43b6-80b1-e6b23752aae613
26404220.8 ML adalimumab-bwwd 50 MG/ML Injection [Hadlima]SBD4774a951-3ce8-43b6-80b1-e6b23752aae613
26403050.8 ML adalimumab-bwwd 50 MG/ML Prefilled Syringe [Hadlima]SBD4774a951-3ce8-43b6-80b1-e6b23752aae613
26404300.4 ML adalimumab-bwwd 100 MG/ML Auto-InjectorSCD4774a951-3ce8-43b6-80b1-e6b23752aae613
26404250.4 ML adalimumab-bwwd 100 MG/ML Prefilled SyringeSCD4774a951-3ce8-43b6-80b1-e6b23752aae613
26402870.8 ML adalimumab-bwwd 50 MG/ML Auto-InjectorSCD4774a951-3ce8-43b6-80b1-e6b23752aae613
26404190.8 ML adalimumab-bwwd 50 MG/ML InjectionSCD4774a951-3ce8-43b6-80b1-e6b23752aae613
26403020.8 ML adalimumab-bwwd 50 MG/ML Prefilled SyringeSCD4774a951-3ce8-43b6-80b1-e6b23752aae613
26404320.4 ML Hadlima 100 MG/ML Auto-InjectorSY4774a951-3ce8-43b6-80b1-e6b23752aae613
26404280.4 ML Hadlima 100 MG/ML Prefilled SyringeSY4774a951-3ce8-43b6-80b1-e6b23752aae613
26403000.8 ML Hadlima 50 MG/ML Auto-InjectorSY4774a951-3ce8-43b6-80b1-e6b23752aae613
26404220.8 ML Hadlima 50 MG/ML InjectionSY4774a951-3ce8-43b6-80b1-e6b23752aae613
26403050.8 ML Hadlima 50 MG/ML Prefilled SyringeSY4774a951-3ce8-43b6-80b1-e6b23752aae613
2640430adalimumab-bwwd 40 MG per 0.4 ML Auto-InjectorSY4774a951-3ce8-43b6-80b1-e6b23752aae613
2640425adalimumab-bwwd 40 MG per 0.4 ML Prefilled SyringeSY4774a951-3ce8-43b6-80b1-e6b23752aae613
2640287adalimumab-bwwd 40 MG per 0.8 ML Auto-InjectorSY4774a951-3ce8-43b6-80b1-e6b23752aae613
2640419adalimumab-bwwd 40 MG per 0.8 ML InjectionSY4774a951-3ce8-43b6-80b1-e6b23752aae613
2640302adalimumab-bwwd 40 MG per 0.8 ML Prefilled SyringeSY4774a951-3ce8-43b6-80b1-e6b23752aae613
2640432Hadlima 40 MG per 0.4 ML Auto-InjectorSY4774a951-3ce8-43b6-80b1-e6b23752aae613
2640428Hadlima 40 MG per 0.4 ML Prefilled SyringeSY4774a951-3ce8-43b6-80b1-e6b23752aae613
2640300Hadlima 40 MG per 0.8 ML Auto-InjectorSY4774a951-3ce8-43b6-80b1-e6b23752aae613
2640422Hadlima 40 MG per 0.8 ML InjectionSY4774a951-3ce8-43b6-80b1-e6b23752aae613
2640305Hadlima 40 MG per 0.8 ML Prefilled SyringeSY4774a951-3ce8-43b6-80b1-e6b23752aae613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78206-185-01782060185011 CARTON in 1 CARTON (78206-185-01) / 1 VIAL in 1 CARTON (78206-185-99) / .8 mL in 1 VIAL1 carton2023-07-01NoNoHistorical
78206-185-99782060185991 in 1 CARTONHistorical