FDA.reportPublic FDA data

Adalimumab

Product NDC
61314-325
11-digit product format
613140325
Labeler code
61314
Product ID
61314-325_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
2025-01-06
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
Adalimumab
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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2641644Internal RxNorm lookup
2641653Internal RxNorm lookup
2641655Internal RxNorm lookup
2641660Internal RxNorm lookup
2641662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3468792f-63ef-4916-8ed1-8214f327d9ddAvailable 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
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
61314-325-20Adalimumab0.8 mL in 1 SYRINGEINJECTION, SOLUTION0.815
61314-325-20Adalimumab2 in 1 CARTONINJECTION, SOLUTION215

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-325-20ML - Milliliter61314-325b4465b48-9d70-4fe2-ad42-eae921415f2512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-325ADALIMUMAB (ADALIMUMAB-ADAZ) INJECTION, SOLUTION [SANDOZ INC]10Current NDC, 2 package rows20250326_3468792f-63ef-4916-8ed1-8214f327d9dd.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
AdalimumabADALIMUMAB-ADAZSandoz Inc3468792f-63ef-4916-8ed1-8214f327d9dd2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761071
ndc (product): 61314-325
HYRIMOZADALIMUMAB-ADAZCordavis Limited3e303a4a-980b-4f2a-9d03-7869287586372025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761071
HYRIMOZADALIMUMAB-ADAZSandoz Inc1ac7d061-3380-468c-b077-c05f8dfbc8292025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761071

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761071Hyrimozadalimumab-adaz351(k) InterchangeableRx2026-07-01

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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
61314-325-20613140325202 SYRINGE in 1 CARTON (61314-325-20) / .8 mL in 1 SYRINGE2 syringe2025-01-06NoNoCurrent