Home NDC 65219-612 Adalimumab-aacf
Product NDC 65219-612
11-digit product format 652190612
Labeler code 65219
Product ID 65219-612_ed59e023-eb91-482f-a1fe-19a31c0906c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name adalimumab
Dosage form KIT
Route SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application BLA761255
Marketing category BLA
Marketing start 2023-12-06
NDC exclude flag No
Listing certified through 2027-12-31
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 ndc (product): 65219-612 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
Additional Listing Data#
Finished product Yes
Brand name base Adalimumab-aacf
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797544 Internal RxNorm lookup 2640851 Internal RxNorm lookup 2640859 Internal RxNorm lookup 2640864 Internal RxNorm lookup 2640869 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 Adalimumab-aacf 1 in 1 POUCH SWAB 2 0.75 g 6 65219-610-02 Adalimumab-aacf 0.8 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1.6 mL 40 mg in 0.8mL 6 65219-612-69 Adalimumab-aacf 1 in 1 CARTON KIT 1 6 65219-612-69 Adalimumab-aacf 2 in 1 CARTON KIT 2 6 65219-612-89 Adalimumab-aacf 3 in 1 CARTON KIT 3 6 65219-612-89 Adalimumab-aacf 1 in 1 CARTON KIT 1 6 65219-612-99 Adalimumab-aacf 1 in 1 CARTON KIT 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-612 ADALIMUMAB-AACF (ADALIMUMAB) KIT [FRESENIUS KABI USA, LLC] 5 Current NDC, 7 package rows 20240826_2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915.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 65219-610-02 65219061002 0.8 mL in 1 SYRINGE, GLASS 0.8 ml Historical 65219-612-69 65219061269 2 CARTON in 1 CARTON (65219-612-69) / 1 KIT in 1 CARTON * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95) 2 carton 2024-09-30 No No Current 65219-612-89 65219061289 3 CARTON in 1 CARTON (65219-612-89) / 1 KIT in 1 CARTON * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95) 3 carton 2024-09-30 No No Current 65219-612-99 65219061299 1 KIT in 1 CARTON (65219-612-99) * .8 mL in 1 SYRINGE, GLASS (65219-610-02) * 1 SWAB in 1 POUCH (65219-332-95) 1 kit 2023-12-06 No No Current