FDA.reportPublic FDA data

HYRIMOZ

Product NDC
61314-509
11-digit product format
613140509
Labeler code
61314
Product ID
61314-509_af358c91-4472-4fb1-87ba-001d67f2b4f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adalimumab-adaz
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sandoz Inc
Application
BLA761071
Marketing category
BLA
Marketing start
2023-07-01
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
HYRIMOZ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADALIMUMAB10 mg/.1mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFYS6T7F842
Rxcui2641644, 2641650, 2641653, 2641654, 2641655, 2641658, 2641660, 2641661, 2641662, 2641663, 2641664, 2641665, 2641666, 2641667, 2641668, 2641669, 2641670, 2641671, 2641672, 2641673

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
61314-509-64HYRIMOZ0.1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.113
61314-509-64HYRIMOZ2 in 1 CARTONINJECTION, SOLUTION213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-509HYRIMOZ (ADALIMUMAB-ADAZ) INJECTION, SOLUTION HYRIMOZ (ADALIMUMAB-ADAZ) KIT [SANDOZ INC]7Current NDC, 2 package rows20240426_1ac7d061-3380-468c-b077-c05f8dfbc829.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2641673{1 (0.4 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]) / 1 (0.8 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]) } Pack [Hyrimoz Pediatric Crohn's Starter Kit Patient Weight < 40 KG]BPCK1ac7d061-3380-468c-b077-c05f8dfbc82913
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]BPCK1ac7d061-3380-468c-b077-c05f8dfbc82913
2641665{3 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]) } Pack [Hyrimoz Crohn's and UC Starter Kit]BPCK1ac7d061-3380-468c-b077-c05f8dfbc82913
2641669{3 (0.8 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]) } Pack [Hyrimoz Pediatric Crohn's Starter Kit Patient Weight > 40 KG]BPCK1ac7d061-3380-468c-b077-c05f8dfbc82913
2641672{1 (0.4 ML adalimumab-adaz 100 MG/ML Prefilled Syringe) / 1 (0.8 ML adalimumab-adaz 100 MG/ML Prefilled Syringe) } PackGPCK1ac7d061-3380-468c-b077-c05f8dfbc82913
2641670{2 (0.4 ML adalimumab-adaz 100 MG/ML Auto-Injector) / 1 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector) } PackGPCK1ac7d061-3380-468c-b077-c05f8dfbc82913
2641664{3 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector) } PackGPCK1ac7d061-3380-468c-b077-c05f8dfbc82913
2641668{3 (0.8 ML adalimumab-adaz 100 MG/ML Prefilled Syringe) } PackGPCK1ac7d061-3380-468c-b077-c05f8dfbc82913
2641644adalimumab-adaz 10 MG in 0.1 ML Prefilled SyringePSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641653adalimumab-adaz 20 MG in 0.2 ML Prefilled SyringePSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641655adalimumab-adaz 40 MG in 0.4 ML Auto-InjectorPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641660adalimumab-adaz 40 MG in 0.4 ML Prefilled SyringePSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641662adalimumab-adaz 80 MG in 0.8 ML Auto-InjectorPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641666adalimumab-adaz 80 MG in 0.8 ML Prefilled SyringePSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641664adalimumab-adaz Crohn's and UC or Hidradenitis Suppurativa Starter PackPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641672adalimumab-adaz Pediatric Crohn's Starter Kit Patient Weight < 40 KGPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641668adalimumab-adaz Pediatric Crohn's Starter Kit Patient Weight > 40 KGPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641670adalimumab-adaz Plaque Psoriasis or Uveitis Starter KitPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641650Hyrimoz 10 MG in 0.1 ML Prefilled SyringePSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641654Hyrimoz 20 MG in 0.2 ML Prefilled SyringePSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641658Hyrimoz 40 MG in 0.4 ML Auto-InjectorPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641661Hyrimoz 40 MG in 0.4 ML Prefilled SyringePSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641663Hyrimoz 80 MG in 0.8 ML Auto-InjectorPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641667Hyrimoz 80 MG in 0.8 ML Prefilled SyringePSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641665Hyrimoz Crohn's and UC or Hidradenitis Suppurativa Starter KitPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641673Hyrimoz Pediatric Crohn's Starter Kit Patient Weight < 40 KGPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641669Hyrimoz Pediatric Crohn's Starter Kit Patient Weight > 40 KGPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
2641671Hyrimoz Plaque Psoriasis or Uveitis Starter KitPSN1ac7d061-3380-468c-b077-c05f8dfbc82913
26416500.1 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]SBD1ac7d061-3380-468c-b077-c05f8dfbc82913
26416540.2 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]SBD1ac7d061-3380-468c-b077-c05f8dfbc82913
26416580.4 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]SBD1ac7d061-3380-468c-b077-c05f8dfbc82913
26416610.4 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]SBD1ac7d061-3380-468c-b077-c05f8dfbc82913
26416630.8 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]SBD1ac7d061-3380-468c-b077-c05f8dfbc82913
26416670.8 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]SBD1ac7d061-3380-468c-b077-c05f8dfbc82913
26416440.1 ML adalimumab-adaz 100 MG/ML Prefilled SyringeSCD1ac7d061-3380-468c-b077-c05f8dfbc82913
26416530.2 ML adalimumab-adaz 100 MG/ML Prefilled SyringeSCD1ac7d061-3380-468c-b077-c05f8dfbc82913
26416550.4 ML adalimumab-adaz 100 MG/ML Auto-InjectorSCD1ac7d061-3380-468c-b077-c05f8dfbc82913
26416600.4 ML adalimumab-adaz 100 MG/ML Prefilled SyringeSCD1ac7d061-3380-468c-b077-c05f8dfbc82913
26416620.8 ML adalimumab-adaz 100 MG/ML Auto-InjectorSCD1ac7d061-3380-468c-b077-c05f8dfbc82913
26416660.8 ML adalimumab-adaz 100 MG/ML Prefilled SyringeSCD1ac7d061-3380-468c-b077-c05f8dfbc82913
2641644adalimumab-adaz 10 MG per 0.1 ML Prefilled SyringeSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641653adalimumab-adaz 20 MG per 0.2 ML Prefilled SyringeSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641655adalimumab-adaz 40 MG per 0.4 ML Auto-InjectorSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641660adalimumab-adaz 40 MG per 0.4 ML Prefilled SyringeSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641662adalimumab-adaz 80 MG per 0.8 ML Auto-InjectorSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641666adalimumab-adaz 80 MG per 0.8 ML Prefilled SyringeSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641664adalimumab-adaz Crohn's and UC or Hidradenitis Suppurativa Starter PackSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641672adalimumab-adaz Pediatric Crohn's Starter Kit Patient Weight < 40 KGSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641668adalimumab-adaz Pediatric Crohn's Starter Kit Patient Weight > 40 KGSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641670adalimumab-adaz Plaque Psoriasis or Uveitis Starter KitSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641650Hyrimoz 10 MG per 0.1 ML Prefilled SyringeSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641654Hyrimoz 20 MG per 0.2 ML Prefilled SyringeSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641658Hyrimoz 40 MG per 0.4 ML Auto-InjectorSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641661Hyrimoz 40 MG per 0.4 ML Prefilled SyringeSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641663Hyrimoz 80 MG per 0.8 ML Auto-InjectorSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641667Hyrimoz 80 MG per 0.8 ML Prefilled SyringeSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641665Hyrimoz Crohn's and UC or Hidradenitis Suppurativa Starter KitSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641673Hyrimoz Pediatric Crohn's Starter Kit Patient Weight < 40 KGSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641669Hyrimoz Pediatric Crohn's Starter Kit Patient Weight > 40 KGSY1ac7d061-3380-468c-b077-c05f8dfbc82913
2641671Hyrimoz Plaque Psoriasis or Uveitis Starter KitSY1ac7d061-3380-468c-b077-c05f8dfbc82913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61314-509-64613140509642 SYRINGE, GLASS in 1 CARTON (61314-509-64) / .1 mL in 1 SYRINGE, GLASS2023-07-01NoNoCurrent