FDA.reportPublic FDA data

AMJEVITA

Product NDC
72511-479
11-digit product format
725110479
Labeler code
72511
Product ID
72511-479_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
2024-11-08
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
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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMJEVITAADALIMUMAB-ATTOAmgen USA Inc.b7178e36-6787-45ab-8fee-be59bc6a4aa42026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761024
ndc (product): 72511-479
AMJEVITAADALIMUMAB-ATTOAmgen, Inc9c44bd5b-4464-40a4-8933-8680950f00f22026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761024
AMJEVITAADALIMUMAB-ATTONuvaila Limitedd7862491-2634-4402-b001-dcc1abf8dd582026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761024

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FYS6T7F842Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2627719Internal RxNorm lookup
2627722Internal RxNorm lookup
2663901Internal RxNorm lookup
2663904Internal RxNorm lookup
2663906Internal RxNorm lookup
2663907Internal RxNorm lookup
2663908Internal RxNorm lookup
2663910Internal RxNorm lookup
2663914Internal RxNorm lookup
2663915Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b7178e36-6787-45ab-8fee-be59bc6a4aa4Available on FDA.report

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
72511-479-02AMJEVITA0.4 mL in 1 SYRINGEINJECTION0.414
72511-479-02AMJEVITA2 in 1 CARTONINJECTION214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72511-479-02ML - Milliliter72511-479541ceda9-d635-4c4d-b033-99ef29fd475712025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72511-479AMJEVITA (ADALIMUMAB-ATTO) INJECTION [AMGEN USA INC.]11Current NDC, 2 package rows20241109_b7178e36-6787-45ab-8fee-be59bc6a4aa4.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761024Amjevitaadalimumab-atto351(k) InterchangeableRx2026-06-01

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
72511-479-02725110479022 SYRINGE in 1 CARTON (72511-479-02) / .4 mL in 1 SYRINGE2 syringe2024-11-08NoNoCurrent