FDA.reportPublic FDA data

AMJEVITA

Product NDC
84612-482
11-digit product format
846120482
Labeler code
84612
Product ID
84612-482_ebaefae6-3b2d-4d1f-8f59-ecc6f0061607
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-atto
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Nuvaila Limited
Application
BLA761024
Marketing category
BLA
Marketing start
2025-01-01
Substance
ADALIMUMAB
Active strength
40 mg/.4mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADALIMUMAB40 mg/.4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFYS6T7F842
Rxcui2663901, 2663904, 2663906, 2663907, 2663908, 2663910, 2663914, 2663915

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
84612-482-01AMJEVITA0.4 mL in 1 SYRINGEINJECTION0.46
84612-482-01AMJEVITA1 in 1 CARTONINJECTION16
84612-482-02AMJEVITA2 in 1 CARTONINJECTION26
84612-482-02AMJEVITA0.4 mL in 1 SYRINGEINJECTION0.46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84612-482-02ML - Milliliter84612-4828bf3d7fa-59aa-49ab-bdeb-7281a288066612025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84612-482AMJEVITA (ADALIMUMAB-ATTO) INJECTION [OPTUM HEALTH SOLUTIONS (IRELAND) LIMITED]2Current NDC, 4 package rows20250209_d7862491-2634-4402-b001-dcc1abf8dd58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2663901adalimumab-atto 20 MG in 0.2 ML Prefilled SyringePSNd7862491-2634-4402-b001-dcc1abf8dd586
2663908adalimumab-atto 40 MG in 0.4 ML Auto-InjectorPSNd7862491-2634-4402-b001-dcc1abf8dd586
2663906adalimumab-atto 40 MG in 0.4 ML Prefilled SyringePSNd7862491-2634-4402-b001-dcc1abf8dd586
2663914adalimumab-atto 80 MG in 0.8 ML Auto-InjectorPSNd7862491-2634-4402-b001-dcc1abf8dd586
2663904AMJEVITA 20 MG in 0.2 ML Prefilled SyringePSNd7862491-2634-4402-b001-dcc1abf8dd586
2663910AMJEVITA 40 MG in 0.4 ML Auto-InjectorPSNd7862491-2634-4402-b001-dcc1abf8dd586
2663907AMJEVITA 40 MG in 0.4 ML Prefilled SyringePSNd7862491-2634-4402-b001-dcc1abf8dd586
2663915AMJEVITA 80 MG in 0.8 ML Auto-InjectorPSNd7862491-2634-4402-b001-dcc1abf8dd586
26639040.2 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]SBDd7862491-2634-4402-b001-dcc1abf8dd586
26639100.4 ML adalimumab-atto 100 MG/ML Auto-Injector [Amjevita]SBDd7862491-2634-4402-b001-dcc1abf8dd586
26639070.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]SBDd7862491-2634-4402-b001-dcc1abf8dd586
26639150.8 ML adalimumab-atto 100 MG/ML Auto-Injector [Amjevita]SBDd7862491-2634-4402-b001-dcc1abf8dd586
26639010.2 ML adalimumab-atto 100 MG/ML Prefilled SyringeSCDd7862491-2634-4402-b001-dcc1abf8dd586
26639080.4 ML adalimumab-atto 100 MG/ML Auto-InjectorSCDd7862491-2634-4402-b001-dcc1abf8dd586
26639060.4 ML adalimumab-atto 100 MG/ML Prefilled SyringeSCDd7862491-2634-4402-b001-dcc1abf8dd586
26639140.8 ML adalimumab-atto 100 MG/ML Auto-InjectorSCDd7862491-2634-4402-b001-dcc1abf8dd586
2663901adalimumab-atto 20 MG per 0.2 ML Prefilled SyringeSYd7862491-2634-4402-b001-dcc1abf8dd586
2663908adalimumab-atto 40 MG per 0.4 ML Auto-InjectorSYd7862491-2634-4402-b001-dcc1abf8dd586
2663906adalimumab-atto 40 MG per 0.4 ML Prefilled SyringeSYd7862491-2634-4402-b001-dcc1abf8dd586
2663914adalimumab-atto 80 MG per 0.8 ML Auto-InjectorSYd7862491-2634-4402-b001-dcc1abf8dd586
2663904Amjevita 20 MG per 0.2 ML Prefilled SyringeSYd7862491-2634-4402-b001-dcc1abf8dd586
2663910Amjevita 40 MG per 0.4 ML Auto-InjectorSYd7862491-2634-4402-b001-dcc1abf8dd586
2663907Amjevita 40 MG per 0.4 ML Prefilled SyringeSYd7862491-2634-4402-b001-dcc1abf8dd586
2663915Amjevita 80 MG per 0.8 ML Auto-InjectorSYd7862491-2634-4402-b001-dcc1abf8dd586

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84612-482-01846120482011 SYRINGE in 1 CARTON (84612-482-01) / .4 mL in 1 SYRINGE1 syringe2025-01-01NoNoCurrent
84612-482-02846120482022 SYRINGE in 1 CARTON (84612-482-02) / .4 mL in 1 SYRINGE2 syringe2025-01-01NoNoCurrent