FDA.reportPublic FDA data

Adalimumab

Product NDC
61314-391
11-digit product format
613140391
Labeler code
61314
Product ID
61314-391_ae54abc4-e9c5-4c5a-8fa7-968e5ad72050
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-adaz
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sandoz Inc
Application
BLA761071
Marketing category
BLA
Marketing start
2025-03-26
Substance
ADALIMUMAB
Active strength
10 mg/.1mL
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
Adalimumab
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADALIMUMAB10 mg/.1mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFYS6T7F842
Rxcui2641644, 2641653, 2641655, 2641660, 2641662

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
652f8f6b-479d-477c-848a-374d5b0145b7Product name220151203
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-391-64Adalimumab0.1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.115
61314-391-64Adalimumab2 in 1 CARTONINJECTION, SOLUTION215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-391ADALIMUMAB (ADALIMUMAB-ADAZ) INJECTION, SOLUTION [SANDOZ INC]10Current NDC, 2 package rows20250326_3468792f-63ef-4916-8ed1-8214f327d9dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2641644adalimumab-adaz 10 MG in 0.1 ML Prefilled SyringePSN3468792f-63ef-4916-8ed1-8214f327d9dd15
2641653adalimumab-adaz 20 MG in 0.2 ML Prefilled SyringePSN3468792f-63ef-4916-8ed1-8214f327d9dd15
2641655adalimumab-adaz 40 MG in 0.4 ML Auto-InjectorPSN3468792f-63ef-4916-8ed1-8214f327d9dd15
2641660adalimumab-adaz 40 MG in 0.4 ML Prefilled SyringePSN3468792f-63ef-4916-8ed1-8214f327d9dd15
2641662adalimumab-adaz 80 MG in 0.8 ML Auto-InjectorPSN3468792f-63ef-4916-8ed1-8214f327d9dd15
26416440.1 ML adalimumab-adaz 100 MG/ML Prefilled SyringeSCD3468792f-63ef-4916-8ed1-8214f327d9dd15
26416530.2 ML adalimumab-adaz 100 MG/ML Prefilled SyringeSCD3468792f-63ef-4916-8ed1-8214f327d9dd15
26416550.4 ML adalimumab-adaz 100 MG/ML Auto-InjectorSCD3468792f-63ef-4916-8ed1-8214f327d9dd15
26416600.4 ML adalimumab-adaz 100 MG/ML Prefilled SyringeSCD3468792f-63ef-4916-8ed1-8214f327d9dd15
26416620.8 ML adalimumab-adaz 100 MG/ML Auto-InjectorSCD3468792f-63ef-4916-8ed1-8214f327d9dd15
2641644adalimumab-adaz 10 MG per 0.1 ML Prefilled SyringeSY3468792f-63ef-4916-8ed1-8214f327d9dd15
2641653adalimumab-adaz 20 MG per 0.2 ML Prefilled SyringeSY3468792f-63ef-4916-8ed1-8214f327d9dd15
2641655adalimumab-adaz 40 MG per 0.4 ML Auto-InjectorSY3468792f-63ef-4916-8ed1-8214f327d9dd15
2641660adalimumab-adaz 40 MG per 0.4 ML Prefilled SyringeSY3468792f-63ef-4916-8ed1-8214f327d9dd15
2641662adalimumab-adaz 80 MG per 0.8 ML Auto-InjectorSY3468792f-63ef-4916-8ed1-8214f327d9dd15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61314-391-64613140391642 SYRINGE, GLASS in 1 CARTON (61314-391-64) / .1 mL in 1 SYRINGE, GLASS2025-03-26NoNoCurrent