FDA.reportPublic FDA data

IDACIO

Product NDC
65219-558
Requested package NDC
65219-558-08
11-digit product format
652190558
Labeler code
65219
Product ID
65219-558_08dbaffe-9d05-43cf-b24b-b44ade8685fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-aacf
Dosage form
KIT
Labeler
Fresenius Kabi USA, LLC
Application
BLA761255
Marketing category
BLA
Marketing start
2024-12-09
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
IdacioADALIMUMAB-AACFFresenius Kabi USA, LLC43de75ac-1a37-4609-9edd-68bda2448a472026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761255
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
ndc (package): 65219-558-08
ndc (product): 65219-558
ndc11 (package): 65219055808

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
2699315Internal RxNorm lookup
2699319Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
08dbaffe-9d05-43cf-b24b-b44ade8685fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
58819a18-327d-463b-9e5e-26cc1dd9870dProduct name120230313
c1c5a070-0e2e-43dd-af9c-a21585200342Product name120230104
2a463079-cd68-4798-a3d6-55c4c8578d57Product name120220728
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-332-95IDACIO1 in 1 POUCHSWAB20.75 g1
65219-558-08IDACIO1 in 1 CARTONKIT11
65219-562-01IDACIO0.8 mL in 1 VIAL, GLASSINJECTION0.8 mL40 mg in 0.8mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-558IDACIO (ADALIMUMAB-AACF) KIT [FRESENIUS KABI USA, LLC]1Current NDC, 3 package rows20241209_08dbaffe-9d05-43cf-b24b-b44ade8685fc.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
2699315adalimumab-aacf 40 MG in 0.8 ML InjectionPSN08dbaffe-9d05-43cf-b24b-b44ade8685fc1
2699319Idacio 40 MG in 0.8 ML InjectionPSN08dbaffe-9d05-43cf-b24b-b44ade8685fc1
797544isopropyl alcohol 70 % Medicated PadPSN08dbaffe-9d05-43cf-b24b-b44ade8685fc1
26993190.8 ML adalimumab-aacf 50 MG/ML Injection [Idacio]SBD08dbaffe-9d05-43cf-b24b-b44ade8685fc1
26993150.8 ML adalimumab-aacf 50 MG/ML InjectionSCD08dbaffe-9d05-43cf-b24b-b44ade8685fc1
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD08dbaffe-9d05-43cf-b24b-b44ade8685fc1
2699315adalimumab-aacf 40 MG per 0.8 ML InjectionSY08dbaffe-9d05-43cf-b24b-b44ade8685fc1
2699319Idacio 40 MG per 0.8 ML InjectionSY08dbaffe-9d05-43cf-b24b-b44ade8685fc1
797544isopropyl alcohol 70 % Medicated PadSY08dbaffe-9d05-43cf-b24b-b44ade8685fc1
797544isopropyl alcohol 70 % Topical ClothSY08dbaffe-9d05-43cf-b24b-b44ade8685fc1
797544isopropyl alcohol 70 % Topical SwabSY08dbaffe-9d05-43cf-b24b-b44ade8685fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-558-08652190558081 KIT in 1 CARTON (65219-558-08) * .8 mL in 1 VIAL, GLASS (65219-562-01) * 1 SWAB in 1 POUCH (65219-332-95) 1 kit2024-12-09NoNoCurrent