Home NDC 65219-558 IDACIO
Product NDC 65219-558
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Idacio ADALIMUMAB-AACF Fresenius Kabi USA, LLC 43de75ac-1a37-4609-9edd-68bda2448a47 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761255 Adalimumab-aacf ADALIMUMAB Fresenius Kabi USA, LLC 2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915 2026-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761255 IDACIO ADALIMUMAB-AACF Fresenius Kabi USA, LLC 08dbaffe-9d05-43cf-b24b-b44ade8685fc 2024-10-15 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761255 ndc (product): 65219-558
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 Identifier FDA.report destination 797544 Internal RxNorm lookup 2699315 Internal RxNorm lookup 2699319 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65219-332-95 IDACIO 1 in 1 POUCH SWAB 2 0.75 g 1 65219-558-08 IDACIO 1 in 1 CARTON KIT 1 1 65219-562-01 IDACIO 0.8 mL in 1 VIAL, GLASS INJECTION 0.8 mL 40 mg in 0.8mL 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-558 IDACIO (ADALIMUMAB-AACF) KIT [FRESENIUS KABI USA, LLC] 1 Current NDC, 3 package rows 20241209_08dbaffe-9d05-43cf-b24b-b44ade8685fc.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761255 Idacio adalimumab-aacf 351(k) Biosimilar Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65219-332-95 65219033295 1 in 1 POUCH Historical 65219-558-08 65219055808 1 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 kit 2024-12-09 No No Current 65219-562-01 65219056201 0.8 mL in 1 VIAL, GLASS 0.8 ml Historical