FDA.reportPublic FDA data

Hadlima

Product NDC
78206-184
11-digit product format
782060184
Labeler code
78206
Product ID
78206-184_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
78206-184-01Hadlima2 in 1 CARTONSOLUTION213
78206-184-99Hadlima1 in 1 CARTONSOLUTION113
78206-184-99Hadlima0.8 mL in 1 SYRINGESOLUTION0.813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-184-01ML - Milliliter78206-1841a6dae95-ef5c-46e2-815a-30dcdea91c7c12023-08-08
78206-184-99ML - Milliliter78206-184ed6d7a98-f07a-40f1-ad05-a20f0106b73412023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-184HADLIMA (ADALIMUMAB-BWWD) SOLUTION [ORGANON LLC]10Current NDC, 3 package rows20240713_4774a951-3ce8-43b6-80b1-e6b23752aae6.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HADLIMAADALIMUMAB-BWWDA-S Medication Solutionsc361dd60-c88d-4f3c-b98c-79687bbc34502026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761059
Adalimumab-bwwdADALIMUMAB-BWWDCordavis Limitedc24655e5-796e-4127-b716-92f08d649c832025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761059
HADLIMAADALIMUMAB-BWWDA-S Medication Solutions7345f276-102e-4175-b7ef-ff1706b054722023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761059
HADLIMAADALIMUMAB-BWWDA-S Medication Solutionsef25af7e-6267-409a-8d68-de51eb48812a2023-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761059

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761059Hadlimaadalimumab-bwwd351(k) InterchangeableRx2026-07-01

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
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
78206-184-01782060184012 CARTON in 1 CARTON (78206-184-01) / 1 SYRINGE in 1 CARTON (78206-184-99) / .8 mL in 1 SYRINGE2 carton2023-07-01NoNoCurrent
78206-184-99782060184991 in 1 CARTONHistorical