FDA.reportPublic FDA data

AMJEVITA

Product NDC
72511-400
11-digit product format
725110400
Labeler code
72511
Product ID
72511-400_51727964-061d-4c73-a22e-0c2e1cd571b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-atto
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amgen USA Inc.
Application
BLA761024
Marketing category
BLA
Marketing start
2023-01-31
Substance
ADALIMUMAB
Active strength
40 mg/.8mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADALIMUMAB40 mg/.8mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFYS6T7F842
Rxcui2627719, 2627722, 2663901, 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
72511-400-01AMJEVITA0.8 mL in 1 SYRINGEINJECTION0.814
72511-400-01AMJEVITA1 in 1 CARTONINJECTION114
72511-400-02AMJEVITA2 in 1 CARTONINJECTION214
72511-400-02AMJEVITA0.8 mL in 1 SYRINGEINJECTION0.814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72511-400-01ML - Milliliter72511-400c0462200-24f0-428b-9857-3ce75caf199712023-03-13
72511-400-02ML - Milliliter72511-40025d6ad17-7ebd-4103-b257-a6484c69f7cb12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72511-400AMJEVITA (ADALIMUMAB-ATTO) INJECTION [AMGEN USA INC.]11Current NDC, 4 package rows20241109_b7178e36-6787-45ab-8fee-be59bc6a4aa4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2663901adalimumab-atto 20 MG in 0.2 ML Prefilled SyringePSNb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663908adalimumab-atto 40 MG in 0.4 ML Auto-InjectorPSNb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663906adalimumab-atto 40 MG in 0.4 ML Prefilled SyringePSNb7178e36-6787-45ab-8fee-be59bc6a4aa414
2627719adalimumab-atto 40 MG in 0.8 ML Auto-InjectorPSNb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663914adalimumab-atto 80 MG in 0.8 ML Auto-InjectorPSNb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663904AMJEVITA 20 MG in 0.2 ML Prefilled SyringePSNb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663910AMJEVITA 40 MG in 0.4 ML Auto-InjectorPSNb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663907AMJEVITA 40 MG in 0.4 ML Prefilled SyringePSNb7178e36-6787-45ab-8fee-be59bc6a4aa414
2627722AMJEVITA 40 MG in 0.8 ML Auto-InjectorPSNb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663915AMJEVITA 80 MG in 0.8 ML Auto-InjectorPSNb7178e36-6787-45ab-8fee-be59bc6a4aa414
26639040.2 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]SBDb7178e36-6787-45ab-8fee-be59bc6a4aa414
26639100.4 ML adalimumab-atto 100 MG/ML Auto-Injector [Amjevita]SBDb7178e36-6787-45ab-8fee-be59bc6a4aa414
26639070.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]SBDb7178e36-6787-45ab-8fee-be59bc6a4aa414
26639150.8 ML adalimumab-atto 100 MG/ML Auto-Injector [Amjevita]SBDb7178e36-6787-45ab-8fee-be59bc6a4aa414
26277220.8 ML adalimumab-atto 50 MG/ML Auto-Injector [Amjevita]SBDb7178e36-6787-45ab-8fee-be59bc6a4aa414
26639010.2 ML adalimumab-atto 100 MG/ML Prefilled SyringeSCDb7178e36-6787-45ab-8fee-be59bc6a4aa414
26639080.4 ML adalimumab-atto 100 MG/ML Auto-InjectorSCDb7178e36-6787-45ab-8fee-be59bc6a4aa414
26639060.4 ML adalimumab-atto 100 MG/ML Prefilled SyringeSCDb7178e36-6787-45ab-8fee-be59bc6a4aa414
26639140.8 ML adalimumab-atto 100 MG/ML Auto-InjectorSCDb7178e36-6787-45ab-8fee-be59bc6a4aa414
26277190.8 ML adalimumab-atto 50 MG/ML Auto-InjectorSCDb7178e36-6787-45ab-8fee-be59bc6a4aa414
26277220.8 ML Amjevita 50 MG/ML Auto-InjectorSYb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663901adalimumab-atto 20 MG per 0.2 ML Prefilled SyringeSYb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663908adalimumab-atto 40 MG per 0.4 ML Auto-InjectorSYb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663906adalimumab-atto 40 MG per 0.4 ML Prefilled SyringeSYb7178e36-6787-45ab-8fee-be59bc6a4aa414
2627719adalimumab-atto 40 MG per 0.8 ML Auto-InjectorSYb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663914adalimumab-atto 80 MG per 0.8 ML Auto-InjectorSYb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663904Amjevita 20 MG per 0.2 ML Prefilled SyringeSYb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663910Amjevita 40 MG per 0.4 ML Auto-InjectorSYb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663907Amjevita 40 MG per 0.4 ML Prefilled SyringeSYb7178e36-6787-45ab-8fee-be59bc6a4aa414
2627722Amjevita 40 MG per 0.8 ML Auto-InjectorSYb7178e36-6787-45ab-8fee-be59bc6a4aa414
2663915Amjevita 80 MG per 0.8 ML Auto-InjectorSYb7178e36-6787-45ab-8fee-be59bc6a4aa414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72511-400-01725110400011 SYRINGE in 1 CARTON (72511-400-01) / .8 mL in 1 SYRINGE1 syringe2023-01-31NoNoHistorical
72511-400-02725110400022 SYRINGE in 1 CARTON (72511-400-02) / .8 mL in 1 SYRINGE2 syringe2023-01-31NoNoHistorical