FDA.reportPublic FDA data

AMJEVITA

Product NDC
84612-481
Requested package NDC
84612-481-01
11-digit product format
846120481
Labeler code
84612
Product ID
84612-481_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
80 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
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
ADALIMUMAB80 mg/.8mL

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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
d7862491-2634-4402-b001-dcc1abf8dd58Available 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
84612-481-01AMJEVITA1 in 1 CARTONINJECTION16
84612-481-01AMJEVITA0.8 mL in 1 SYRINGEINJECTION0.86
84612-481-02AMJEVITA0.8 mL in 1 SYRINGEINJECTION0.86
84612-481-02AMJEVITA2 in 1 CARTONINJECTION26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84612-481-02ML - Milliliter84612-48126c9d47b-9482-4345-a262-03beae6c89d812025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84612-481AMJEVITA (ADALIMUMAB-ATTO) INJECTION [OPTUM HEALTH SOLUTIONS (IRELAND) LIMITED]2Current NDC, 4 package rows20250209_d7862491-2634-4402-b001-dcc1abf8dd58.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
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
ndc (package): 84612-481-01
ndc (product): 84612-481
ndc11 (package): 84612048101

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 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
84612-481-01846120481011 SYRINGE in 1 CARTON (84612-481-01) / .8 mL in 1 SYRINGE1 syringe2025-01-01NoNoCurrent