FDA.reportPublic FDA data

Idacio

Product NDC
65219-554
11-digit product format
652190554
Labeler code
65219
Product ID
65219-554_f286c1d4-a9f6-45dd-a8a4-c0065e1a51d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-aacf
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
BLA761255
Marketing category
BLA
Marketing start
2023-07-01
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65219-55465219-554-08DDiscontinued by firm2026-07-31

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
IdacioADALIMUMAB-AACFFresenius Kabi USA, LLC43de75ac-1a37-4609-9edd-68bda2448a472026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761255
ndc (product): 65219-554
Adalimumab-aacfADALIMUMABFresenius Kabi USA, LLC2488b0bc-7b8f-4cc8-91ea-48e7ea5e89152026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761255
IDACIOADALIMUMAB-AACFFresenius Kabi USA, LLC08dbaffe-9d05-43cf-b24b-b44ade8685fc2024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761255

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2640851Internal RxNorm lookup
2640857Internal RxNorm lookup
2640859Internal RxNorm lookup
2640862Internal RxNorm lookup
2640864Internal RxNorm lookup
2640865Internal RxNorm lookup
2640869Internal RxNorm lookup
2640870Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43de75ac-1a37-4609-9edd-68bda2448a47Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-332-95Idacio1 in 1 POUCHSWAB20.75 g7
65219-554-08Idacio1 in 1 CARTONKIT17
65219-554-28Idacio2 in 1 CARTONKIT27
65219-554-28Idacio1 in 1 KITKIT17
65219-554-38Idacio3 in 1 CARTONKIT37
65219-554-38Idacio1 in 1 KITKIT17
65219-574-04Idacio0.8 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1.6 mL40 mg in 0.8mL7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-554-08EA - Each65219-55463dbbbde-7d79-4058-82d7-6e170d563a8212023-07-06
65219-554-28EA - Each65219-55430f87ae6-da2a-4e76-aee5-f176c42d113f12023-07-06
65219-554-38EA - Each65219-5549c2462b2-02ab-45bf-9185-17e10c0e66c412023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-554IDACIO (ADALIMUMAB-AACF) KIT [FRESENIUS KABI USA, LLC]5Current NDC, 7 package rows20250110_43de75ac-1a37-4609-9edd-68bda2448a47.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761255Idacioadalimumab-aacf351(k) BiosimilarRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640865{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector [Idacio]) } Pack [Idacio Pen 40 MG/0.8 ML Starter Pack - Plaque Psoriasis]BPCK43de75ac-1a37-4609-9edd-68bda2448a477
2640870{6 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector [Idacio]) } Pack [Idacio Pen 40 MG/0.8 ML Starter Package for Crohn's Disease or Ulcerative Colitis]BPCK43de75ac-1a37-4609-9edd-68bda2448a477
2640864{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } PackGPCK43de75ac-1a37-4609-9edd-68bda2448a477
2640869{6 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } PackGPCK43de75ac-1a37-4609-9edd-68bda2448a477
2640859adalimumab-aacf 40 MG in 0.8 ML Auto-InjectorPSN43de75ac-1a37-4609-9edd-68bda2448a477
2640851adalimumab-aacf 40 MG in 0.8 ML Prefilled SyringePSN43de75ac-1a37-4609-9edd-68bda2448a477
2640864adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (4 count)PSN43de75ac-1a37-4609-9edd-68bda2448a477
2640869adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (6 count)PSN43de75ac-1a37-4609-9edd-68bda2448a477
2640862Idacio 40 MG in 0.8 ML Auto-InjectorPSN43de75ac-1a37-4609-9edd-68bda2448a477
2640857Idacio 40 MG in 0.8 ML Prefilled SyringePSN43de75ac-1a37-4609-9edd-68bda2448a477
2640870Idacio Pen 40 MG/0.8 ML - Starter Package for Crohn's Disease or Ulcerative Colitis (6 count)PSN43de75ac-1a37-4609-9edd-68bda2448a477
2640865Idacio Pen 40 MG/0.8 ML Starter Pack - Plaque Psoriasis (4 count)PSN43de75ac-1a37-4609-9edd-68bda2448a477
797544isopropyl alcohol 70 % Medicated PadPSN43de75ac-1a37-4609-9edd-68bda2448a477
26408620.8 ML adalimumab-aacf 50 MG/ML Auto-Injector [Idacio]SBD43de75ac-1a37-4609-9edd-68bda2448a477
26408570.8 ML adalimumab-aacf 50 MG/ML Prefilled Syringe [Idacio]SBD43de75ac-1a37-4609-9edd-68bda2448a477
26408590.8 ML adalimumab-aacf 50 MG/ML Auto-InjectorSCD43de75ac-1a37-4609-9edd-68bda2448a477
26408510.8 ML adalimumab-aacf 50 MG/ML Prefilled SyringeSCD43de75ac-1a37-4609-9edd-68bda2448a477
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD43de75ac-1a37-4609-9edd-68bda2448a477
26408620.8 ML Idacio 50 MG/ML Auto-InjectorSY43de75ac-1a37-4609-9edd-68bda2448a477
26408570.8 ML Idacio 50 MG/ML Prefilled SyringeSY43de75ac-1a37-4609-9edd-68bda2448a477
2640859adalimumab-aacf 40 MG per 0.8 ML Auto-InjectorSY43de75ac-1a37-4609-9edd-68bda2448a477
2640851adalimumab-aacf 40 MG per 0.8 ML Prefilled SyringeSY43de75ac-1a37-4609-9edd-68bda2448a477
2640864adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (4 count)SY43de75ac-1a37-4609-9edd-68bda2448a477
2640869adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (6 count)SY43de75ac-1a37-4609-9edd-68bda2448a477
2640862Idacio 40 MG per 0.8 ML Auto-InjectorSY43de75ac-1a37-4609-9edd-68bda2448a477
2640857Idacio 40 MG per 0.8 ML Prefilled SyringeSY43de75ac-1a37-4609-9edd-68bda2448a477
2640870Idacio Pen 40 MG/0.8 ML - Starter Package for Crohn's Disease or Ulcerative Colitis (6 count)SY43de75ac-1a37-4609-9edd-68bda2448a477
2640865Idacio Pen 40 MG/0.8 ML Starter Pack - Plaque Psoriasis (4 count)SY43de75ac-1a37-4609-9edd-68bda2448a477
797544isopropyl alcohol 70 % Medicated PadSY43de75ac-1a37-4609-9edd-68bda2448a477
797544isopropyl alcohol 70 % Topical ClothSY43de75ac-1a37-4609-9edd-68bda2448a477
797544isopropyl alcohol 70 % Topical SwabSY43de75ac-1a37-4609-9edd-68bda2448a477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-332-95652190332951 in 1 POUCHHistorical
65219-554-08652190554081 in 1 CARTONHistorical
65219-554-28652190554282 KIT in 1 CARTON (65219-554-28) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95) 2 kit2023-07-01NoNoCurrent
65219-554-38652190554383 KIT in 1 CARTON (65219-554-38) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE, GLASS (65219-574-04) * 1 SWAB in 1 POUCH (65219-332-95) 3 kit2023-07-01NoNoCurrent
65219-574-04652190574040.8 mL in 1 SYRINGE, GLASS0.8 mlHistorical