FDA.reportPublic FDA data

HADLIMA

Product NDC
50090-8167
Requested package NDC
50090-8167-0
11-digit product format
500908167
Labeler code
50090
Product ID
50090-8167_2332aca7-9905-44cf-be37-2a6a732cf50e
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADALIMUMAB40 mg/.8mL

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
2640287Internal RxNorm lookup
2640300Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7f9da92-ff5d-4260-b4bd-e3f6993a36aeAvailable on FDA.report

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 · 3 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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761059Hadlimaadalimumab-bwwd351(k) InterchangeableRx2026-10-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-8167-0500908167002 SYRINGE in 1 CARTON (50090-8167-0) / .8 mL in 1 SYRINGE2 syringe2026-10-26NoNoCurrent