FDA.reportPublic FDA data

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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui797544, 2640851, 2640859, 2640864, 2640869

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
65219-332-95Adalimumab-aacf1 in 1 POUCHSWAB20.75 g6
65219-610-02Adalimumab-aacf0.8 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1.6 mL40 mg in 0.8mL6
65219-612-69Adalimumab-aacf1 in 1 CARTONKIT16
65219-612-69Adalimumab-aacf2 in 1 CARTONKIT26
65219-612-89Adalimumab-aacf3 in 1 CARTONKIT36
65219-612-89Adalimumab-aacf1 in 1 CARTONKIT16
65219-612-99Adalimumab-aacf1 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-612-69EA - Each65219-61266847fcb-7ee6-4294-a162-a9cb424bfa9712024-10-04
65219-612-89EA - Each65219-612596b1ae0-b4c4-4e6d-9277-204de9fd0e1112024-10-04
65219-612-99EA - Each65219-61272081ca8-e1f9-443e-8cae-9b28ab4a703e12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-612ADALIMUMAB-AACF (ADALIMUMAB) KIT [FRESENIUS KABI USA, LLC]5Current NDC, 7 package rows20240826_2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640864{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } PackGPCK2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
2640869{6 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } PackGPCK2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
2640859adalimumab-aacf 40 MG in 0.8 ML Auto-InjectorPSN2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
2640851adalimumab-aacf 40 MG in 0.8 ML Prefilled SyringePSN2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
2640864adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (4 count)PSN2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
2640869adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (6 count)PSN2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
797544isopropyl alcohol 70 % Medicated PadPSN2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
26408590.8 ML adalimumab-aacf 50 MG/ML Auto-InjectorSCD2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
26408510.8 ML adalimumab-aacf 50 MG/ML Prefilled SyringeSCD2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
2640859adalimumab-aacf 40 MG per 0.8 ML Auto-InjectorSY2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
2640851adalimumab-aacf 40 MG per 0.8 ML Prefilled SyringeSY2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
2640864adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (4 count)SY2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
2640869adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (6 count)SY2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
797544isopropyl alcohol 70 % Medicated PadSY2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
797544isopropyl alcohol 70 % Topical ClothSY2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156
797544isopropyl alcohol 70 % Topical SwabSY2488b0bc-7b8f-4cc8-91ea-48e7ea5e89156

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-332-95652190332951 in 1 POUCHHistorical
65219-610-02652190610020.8 mL in 1 SYRINGE, GLASS0.8 mlHistorical
65219-612-69652190612692 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 carton2024-09-30NoNoHistorical
65219-612-89652190612893 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 carton2024-09-30NoNoHistorical
65219-612-99652190612991 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 kit2023-12-06NoNoHistorical