FDA.reportPublic FDA data

Adalimumab-adbm

Product NDC
82009-144
11-digit product format
820090144
Labeler code
82009
Product ID
82009-144_64b7451d-b06d-486b-9b34-a55001711063
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adalimumab-adbm
Dosage form
KIT
Labeler
QUALLENT PHARMACEUTICALS HEALTH LLC
Application
BLA761058
Marketing category
BLA
Marketing start
2024-04-30
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyltezoADALIMUMAB-ADBMBoehringer Ingelheim Pharmaceuticals, Inc.115ea79b-7209-7f19-b35d-36ec0828fbf52026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761058
Adalimumab-adbmADALIMUMAB-ADBMBoehringer Ingelheim Pharmaceuticals, Inc.62f39a7c-00df-4519-a8d4-39bbd0a649ed2025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761058
Adalimumab-adbmADALIMUMAB-ADBMQUALLENT PHARMACEUTICALS HEALTH LLCf9986706-9c75-4335-a54f-09d7716dbcef2024-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761058
ndc (product): 82009-144

Additional Listing Data#

Finished product
Yes
Brand name base
Adalimumab-adbm
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2640883Internal RxNorm lookup
2640895Internal RxNorm lookup
2680743Internal RxNorm lookup
2680748Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9986706-9c75-4335-a54f-09d7716dbcefAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82009-144-22Adalimumab-adbm2 in 1 CARTONKIT23
82009-144-22Adalimumab-adbm1 in 1 KITKIT13
82009-145-11Adalimumab-adbm0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.4 mL40 mg in 0.4mL3
82009-145-11Adalimumab-adbm1 in 1 TRAYINJECTION, SOLUTION40 mg in 0.4mL3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-144-22EA - Each82009-1448c6a1c9e-339d-4254-8e75-db92a943a24412024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-144ADALIMUMAB-ADBM KIT [QUALLENT PHARMACEUTICALS HEALTH LLC]1Current NDC, 4 package rows20240508_f9986706-9c75-4335-a54f-09d7716dbcef.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761058Cyltezoadalimumab-adbm351(k) InterchangeableRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2680748adalimumab-adbm 40 MG in 0.4 ML Auto-InjectorPSNf9986706-9c75-4335-a54f-09d7716dbcef3
2680743adalimumab-adbm 40 MG in 0.4 ML Prefilled SyringePSNf9986706-9c75-4335-a54f-09d7716dbcef3
2640895adalimumab-adbm 40 MG in 0.8 ML Auto-InjectorPSNf9986706-9c75-4335-a54f-09d7716dbcef3
2640883adalimumab-adbm 40 MG in 0.8 ML Prefilled SyringePSNf9986706-9c75-4335-a54f-09d7716dbcef3
797544isopropyl alcohol 70 % Medicated PadPSNf9986706-9c75-4335-a54f-09d7716dbcef3
26807480.4 ML adalimumab-adbm 100 MG/ML Auto-InjectorSCDf9986706-9c75-4335-a54f-09d7716dbcef3
26807430.4 ML adalimumab-adbm 100 MG/ML Prefilled SyringeSCDf9986706-9c75-4335-a54f-09d7716dbcef3
26408950.8 ML adalimumab-adbm 50 MG/ML Auto-InjectorSCDf9986706-9c75-4335-a54f-09d7716dbcef3
26408830.8 ML adalimumab-adbm 50 MG/ML Prefilled SyringeSCDf9986706-9c75-4335-a54f-09d7716dbcef3
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDf9986706-9c75-4335-a54f-09d7716dbcef3
2680748adalimumab-adbm 40 MG per 0.4 ML Auto-InjectorSYf9986706-9c75-4335-a54f-09d7716dbcef3
2680743adalimumab-adbm 40 MG per 0.4 ML Prefilled SyringeSYf9986706-9c75-4335-a54f-09d7716dbcef3
2640895adalimumab-adbm 40 MG per 0.8 ML Auto-InjectorSYf9986706-9c75-4335-a54f-09d7716dbcef3
2640883adalimumab-adbm 40 MG per 0.8 ML Prefilled SyringeSYf9986706-9c75-4335-a54f-09d7716dbcef3
797544isopropyl alcohol 70 % Medicated PadSYf9986706-9c75-4335-a54f-09d7716dbcef3
797544isopropyl alcohol 70 % Topical ClothSYf9986706-9c75-4335-a54f-09d7716dbcef3
797544isopropyl alcohol 70 % Topical SwabSYf9986706-9c75-4335-a54f-09d7716dbcef3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82009-144-22820090144222 KIT in 1 CARTON (82009-144-22) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (82009-145-11) / .4 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET2 kit2024-04-30NoNoCurrent
82009-145-11820090145110.4 mL in 1 SYRINGE0.4 mlHistorical