FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FYS6T7F842Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2640430Internal RxNorm lookup
2640432Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c361dd60-c88d-4f3c-b98c-79687bbc3450Available on FDA.report

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

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
ndc (product): 50090-6707
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-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