FDA.reportPublic FDA data

HULIO

Product NDC
83257-019
11-digit product format
832570019
Labeler code
83257
Product ID
83257-019_e4767905-1306-0022-2a53-8c5d4b218e2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-fkjp
Dosage form
KIT
Labeler
Biocon Biologics Inc
Application
BLA761154
Marketing category
BLA
Marketing start
2023-12-30
Marketing end
2026-10-31
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HULIO

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui797544, 2640404, 2640410, 2640412, 2640415, 2640417, 2640418

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
83257-019-32HULIO2 in 1 KITKIT211
83257-019-32HULIO1 in 1 TRAYKIT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83257-019-32EA - Each83257-019f67f467f-cdec-424e-88ea-4afb83a544a812024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-019HULIO (ADALIMUMAB-FKJP) KIT [BIOCON BIOLOGICS INC]7Current NDC, 2 package rows20250228_661ad70b-c313-2899-8a7e-7a67bd897ca9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640412adalimumab-fkjp 20 MG in 0.4 ML Prefilled SyringePSN661ad70b-c313-2899-8a7e-7a67bd897ca911
2640404adalimumab-fkjp 40 MG in 0.8 ML Auto-InjectorPSN661ad70b-c313-2899-8a7e-7a67bd897ca911
2640417adalimumab-fkjp 40 MG in 0.8 ML Prefilled SyringePSN661ad70b-c313-2899-8a7e-7a67bd897ca911
2640415Hulio 20 MG in 0.4 ML Prefilled SyringePSN661ad70b-c313-2899-8a7e-7a67bd897ca911
2640410Hulio 40 MG in 0.8 ML Auto-InjectorPSN661ad70b-c313-2899-8a7e-7a67bd897ca911
2640418Hulio 40 MG in 0.8 ML Prefilled SyringePSN661ad70b-c313-2899-8a7e-7a67bd897ca911
797544isopropyl alcohol 70 % Medicated PadPSN661ad70b-c313-2899-8a7e-7a67bd897ca911
26404150.4 ML adalimumab-fkjp 50 MG/ML Prefilled Syringe [Hulio]SBD661ad70b-c313-2899-8a7e-7a67bd897ca911
26404100.8 ML adalimumab-fkjp 50 MG/ML Auto-Injector [Hulio]SBD661ad70b-c313-2899-8a7e-7a67bd897ca911
26404180.8 ML adalimumab-fkjp 50 MG/ML Prefilled Syringe [Hulio]SBD661ad70b-c313-2899-8a7e-7a67bd897ca911
26404120.4 ML adalimumab-fkjp 50 MG/ML Prefilled SyringeSCD661ad70b-c313-2899-8a7e-7a67bd897ca911
26404040.8 ML adalimumab-fkjp 50 MG/ML Auto-InjectorSCD661ad70b-c313-2899-8a7e-7a67bd897ca911
26404170.8 ML adalimumab-fkjp 50 MG/ML Prefilled SyringeSCD661ad70b-c313-2899-8a7e-7a67bd897ca911
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD661ad70b-c313-2899-8a7e-7a67bd897ca911
26404150.4 ML Hulio 50 MG/ML Prefilled SyringeSY661ad70b-c313-2899-8a7e-7a67bd897ca911
26404100.8 ML Hulio 50 MG/ML Auto-InjectorSY661ad70b-c313-2899-8a7e-7a67bd897ca911
26404180.8 ML Hulio 50 MG/ML Prefilled SyringeSY661ad70b-c313-2899-8a7e-7a67bd897ca911
2640412adalimumab-fkjp 20 MG per 0.4 ML Prefilled SyringeSY661ad70b-c313-2899-8a7e-7a67bd897ca911
2640404adalimumab-fkjp 40 MG per 0.8 ML Auto-InjectorSY661ad70b-c313-2899-8a7e-7a67bd897ca911
2640417adalimumab-fkjp 40 MG per 0.8 ML Prefilled SyringeSY661ad70b-c313-2899-8a7e-7a67bd897ca911
2640415Hulio 20 MG per 0.4 ML Prefilled SyringeSY661ad70b-c313-2899-8a7e-7a67bd897ca911
2640410Hulio 40 MG per 0.8 ML Auto-InjectorSY661ad70b-c313-2899-8a7e-7a67bd897ca911
2640418Hulio 40 MG per 0.8 ML Prefilled SyringeSY661ad70b-c313-2899-8a7e-7a67bd897ca911
797544isopropyl alcohol 70 % Medicated PadSY661ad70b-c313-2899-8a7e-7a67bd897ca911
797544isopropyl alcohol 70 % Topical ClothSY661ad70b-c313-2899-8a7e-7a67bd897ca911
797544isopropyl alcohol 70 % Topical SwabSY661ad70b-c313-2899-8a7e-7a67bd897ca911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83257-019-32832570019322 TRAY in 1 KIT (83257-019-32) / 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 tray2023-12-302026-10-31NoNoHistorical