FDA.reportPublic FDA data

Adalimumab

Product NDC
83257-021
11-digit product format
832570021
Labeler code
83257
Product ID
83257-021_ce598802-5148-0115-bd4c-fea7dd51fb90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-fkjp
Dosage form
KIT
Labeler
Biocon Biologics Inc
Application
BLA761154
Marketing category
BLA
Marketing start
2024-04-15
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2640404Internal RxNorm lookup
2640412Internal RxNorm lookup
2640417Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5cde907d-6747-0e62-db25-1718ee717fe7Available on FDA.report

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
83257-021-42Adalimumab1 in 1 TRAYKIT14
83257-021-42Adalimumab2 in 1 KITKIT24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83257-021-42EA - Each83257-0212198b1ac-789d-4de5-9ce1-3c8f3c6eca3a12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-021ADALIMUMAB (ADALIMUMAB-FKJP) KIT [BIOCON BIOLOGICS INC]2Current NDC, 2 package rows20240527_5cde907d-6747-0e62-db25-1718ee717fe7.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdalimumabADALIMUMAB-FKJPBiocon Biologics Inc5cde907d-6747-0e62-db25-1718ee717fe72026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761154
ndc (product): 83257-021
HULIOADALIMUMAB-FKJPBiocon Biologics Inc661ad70b-c313-2899-8a7e-7a67bd897ca92025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761154

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761154Hulioadalimumab-fkjp351(k) InterchangeableRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640412adalimumab-fkjp 20 MG in 0.4 ML Prefilled SyringePSN5cde907d-6747-0e62-db25-1718ee717fe74
2640404adalimumab-fkjp 40 MG in 0.8 ML Auto-InjectorPSN5cde907d-6747-0e62-db25-1718ee717fe74
2640417adalimumab-fkjp 40 MG in 0.8 ML Prefilled SyringePSN5cde907d-6747-0e62-db25-1718ee717fe74
797544isopropyl alcohol 70 % Medicated PadPSN5cde907d-6747-0e62-db25-1718ee717fe74
26404120.4 ML adalimumab-fkjp 50 MG/ML Prefilled SyringeSCD5cde907d-6747-0e62-db25-1718ee717fe74
26404040.8 ML adalimumab-fkjp 50 MG/ML Auto-InjectorSCD5cde907d-6747-0e62-db25-1718ee717fe74
26404170.8 ML adalimumab-fkjp 50 MG/ML Prefilled SyringeSCD5cde907d-6747-0e62-db25-1718ee717fe74
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD5cde907d-6747-0e62-db25-1718ee717fe74
2640412adalimumab-fkjp 20 MG per 0.4 ML Prefilled SyringeSY5cde907d-6747-0e62-db25-1718ee717fe74
2640404adalimumab-fkjp 40 MG per 0.8 ML Auto-InjectorSY5cde907d-6747-0e62-db25-1718ee717fe74
2640417adalimumab-fkjp 40 MG per 0.8 ML Prefilled SyringeSY5cde907d-6747-0e62-db25-1718ee717fe74
797544isopropyl alcohol 70 % Medicated PadSY5cde907d-6747-0e62-db25-1718ee717fe74
797544isopropyl alcohol 70 % Topical ClothSY5cde907d-6747-0e62-db25-1718ee717fe74
797544isopropyl alcohol 70 % Topical SwabSY5cde907d-6747-0e62-db25-1718ee717fe74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83257-021-42832570021422 TRAY in 1 KIT (83257-021-42) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT / 1 mL in 1 PACKET2 tray2024-04-15NoNoCurrent