FDA.reportPublic FDA data

HYRIMOZ

Product NDC
83457-101
11-digit product format
834570101
Labeler code
83457
Product ID
83457-101_04bedd16-44e8-4761-bb65-d4678c4013af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-adaz
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Cordavis Limited
Application
BLA761071
Marketing category
BLA
Marketing start
2023-09-21
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYRIMOZ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADALIMUMAB40 mg/.4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFYS6T7F842
Rxcui2641653, 2641654, 2641655, 2641658, 2641660, 2641661, 2641662, 2641663, 2641664, 2641665, 2641670, 2641671, 2665419, 2665422, 2665424, 2665426

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
83457-101-01HYRIMOZ0.4 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.47
83457-101-01HYRIMOZ2 in 1 CARTONINJECTION, SOLUTION27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83457-101-01ML - Milliliter83457-1012c2e2193-ae50-4d88-947a-633d4200c7c812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83457-101HYRIMOZ (ADALIMUMAB-ADAZ) INJECTION, SOLUTION HYRIMOZ (ADALIMUMAB-ADAZ) KIT [CORDAVIS LIMITED]4Current NDC, 2 package rows20240425_3e303a4a-980b-4f2a-9d03-786928758637.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2641671{2 (0.4 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]) / 1 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]) } Pack [Hyrimoz Plaque Psoriasis Starter Kit]BPCK3e303a4a-980b-4f2a-9d03-7869287586377
2641665{3 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]) } Pack [Hyrimoz Crohn's and UC Starter Kit]BPCK3e303a4a-980b-4f2a-9d03-7869287586377
2641670{2 (0.4 ML adalimumab-adaz 100 MG/ML Auto-Injector) / 1 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector) } PackGPCK3e303a4a-980b-4f2a-9d03-7869287586377
2641664{3 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector) } PackGPCK3e303a4a-980b-4f2a-9d03-7869287586377
2641653adalimumab-adaz 20 MG in 0.2 ML Prefilled SyringePSN3e303a4a-980b-4f2a-9d03-7869287586377
2641655adalimumab-adaz 40 MG in 0.4 ML Auto-InjectorPSN3e303a4a-980b-4f2a-9d03-7869287586377
2641660adalimumab-adaz 40 MG in 0.4 ML Prefilled SyringePSN3e303a4a-980b-4f2a-9d03-7869287586377
2665419adalimumab-adaz 40 MG in 0.8 ML Auto-InjectorPSN3e303a4a-980b-4f2a-9d03-7869287586377
2665424adalimumab-adaz 40 MG in 0.8 ML Prefilled SyringePSN3e303a4a-980b-4f2a-9d03-7869287586377
2641662adalimumab-adaz 80 MG in 0.8 ML Auto-InjectorPSN3e303a4a-980b-4f2a-9d03-7869287586377
2641664adalimumab-adaz Crohn's and UC or Hidradenitis Suppurativa Starter PackPSN3e303a4a-980b-4f2a-9d03-7869287586377
2641670adalimumab-adaz Plaque Psoriasis or Uveitis Starter KitPSN3e303a4a-980b-4f2a-9d03-7869287586377
2641654Hyrimoz 20 MG in 0.2 ML Prefilled SyringePSN3e303a4a-980b-4f2a-9d03-7869287586377
2641658Hyrimoz 40 MG in 0.4 ML Auto-InjectorPSN3e303a4a-980b-4f2a-9d03-7869287586377
2641661Hyrimoz 40 MG in 0.4 ML Prefilled SyringePSN3e303a4a-980b-4f2a-9d03-7869287586377
2665422Hyrimoz 40 MG in 0.8 ML Auto-InjectorPSN3e303a4a-980b-4f2a-9d03-7869287586377
2665426Hyrimoz 40 MG in 0.8 ML Prefilled SyringePSN3e303a4a-980b-4f2a-9d03-7869287586377
2641663Hyrimoz 80 MG in 0.8 ML Auto-InjectorPSN3e303a4a-980b-4f2a-9d03-7869287586377
2641665Hyrimoz Crohn's and UC or Hidradenitis Suppurativa Starter KitPSN3e303a4a-980b-4f2a-9d03-7869287586377
2641671Hyrimoz Plaque Psoriasis or Uveitis Starter KitPSN3e303a4a-980b-4f2a-9d03-7869287586377
26416540.2 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]SBD3e303a4a-980b-4f2a-9d03-7869287586377
26416580.4 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]SBD3e303a4a-980b-4f2a-9d03-7869287586377
26416610.4 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]SBD3e303a4a-980b-4f2a-9d03-7869287586377
26416630.8 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]SBD3e303a4a-980b-4f2a-9d03-7869287586377
26654220.8 ML adalimumab-adaz 50 MG/ML Auto-Injector [Hyrimoz]SBD3e303a4a-980b-4f2a-9d03-7869287586377
26654260.8 ML adalimumab-adaz 50 MG/ML Prefilled Syringe [Hyrimoz]SBD3e303a4a-980b-4f2a-9d03-7869287586377
26416530.2 ML adalimumab-adaz 100 MG/ML Prefilled SyringeSCD3e303a4a-980b-4f2a-9d03-7869287586377
26416550.4 ML adalimumab-adaz 100 MG/ML Auto-InjectorSCD3e303a4a-980b-4f2a-9d03-7869287586377
26416600.4 ML adalimumab-adaz 100 MG/ML Prefilled SyringeSCD3e303a4a-980b-4f2a-9d03-7869287586377
26416620.8 ML adalimumab-adaz 100 MG/ML Auto-InjectorSCD3e303a4a-980b-4f2a-9d03-7869287586377
26654190.8 ML adalimumab-adaz 50 MG/ML Auto-InjectorSCD3e303a4a-980b-4f2a-9d03-7869287586377
26654240.8 ML adalimumab-adaz 50 MG/ML Prefilled SyringeSCD3e303a4a-980b-4f2a-9d03-7869287586377
26654220.8 ML Hyrimoz 50 MG/ML Auto-InjectorSY3e303a4a-980b-4f2a-9d03-7869287586377
26654260.8 ML Hyrimoz 50 MG/ML Prefilled SyringeSY3e303a4a-980b-4f2a-9d03-7869287586377
2641653adalimumab-adaz 20 MG per 0.2 ML Prefilled SyringeSY3e303a4a-980b-4f2a-9d03-7869287586377
2641655adalimumab-adaz 40 MG per 0.4 ML Auto-InjectorSY3e303a4a-980b-4f2a-9d03-7869287586377
2641660adalimumab-adaz 40 MG per 0.4 ML Prefilled SyringeSY3e303a4a-980b-4f2a-9d03-7869287586377
2665419adalimumab-adaz 40 MG per 0.8 ML Auto-InjectorSY3e303a4a-980b-4f2a-9d03-7869287586377
2665424adalimumab-adaz 40 MG per 0.8 ML Prefilled SyringeSY3e303a4a-980b-4f2a-9d03-7869287586377
2641662adalimumab-adaz 80 MG per 0.8 ML Auto-InjectorSY3e303a4a-980b-4f2a-9d03-7869287586377
2641664adalimumab-adaz Crohn's and UC or Hidradenitis Suppurativa Starter PackSY3e303a4a-980b-4f2a-9d03-7869287586377
2641670adalimumab-adaz Plaque Psoriasis or Uveitis Starter KitSY3e303a4a-980b-4f2a-9d03-7869287586377
2641654Hyrimoz 20 MG per 0.2 ML Prefilled SyringeSY3e303a4a-980b-4f2a-9d03-7869287586377
2641658Hyrimoz 40 MG per 0.4 ML Auto-InjectorSY3e303a4a-980b-4f2a-9d03-7869287586377
2641661Hyrimoz 40 MG per 0.4 ML Prefilled SyringeSY3e303a4a-980b-4f2a-9d03-7869287586377
2665422Hyrimoz 40 MG per 0.8 ML Auto-InjectorSY3e303a4a-980b-4f2a-9d03-7869287586377
2665426Hyrimoz 40 MG per 0.8 ML Prefilled SyringeSY3e303a4a-980b-4f2a-9d03-7869287586377
2641663Hyrimoz 80 MG per 0.8 ML Auto-InjectorSY3e303a4a-980b-4f2a-9d03-7869287586377
2641665Hyrimoz Crohn's and UC or Hidradenitis Suppurativa Starter KitSY3e303a4a-980b-4f2a-9d03-7869287586377
2641671Hyrimoz Plaque Psoriasis or Uveitis Starter KitSY3e303a4a-980b-4f2a-9d03-7869287586377

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83457-101-01834570101012 SYRINGE, GLASS in 1 CARTON (83457-101-01) / .4 mL in 1 SYRINGE, GLASS2023-09-21NoNoHistorical