HYRIMOZ

Product NDC: 83457-113
11-digit product format: 834570113
Labeler code: 83457
Product ID: 83457-113_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: 2023-12-15
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: HYRIMOZ
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ADALIMUMAB	80 mg/.8mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	FYS6T7F842
Rxcui	2641653, 2641654, 2641655, 2641658, 2641660, 2641661, 2641662, 2641663, 2641664, 2641665, 2641670, 2641671, 2665419, 2665422, 2665424, 2665426

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58819a18-327d-463b-9e5e-26cc1dd9870d	Product name	1	20230313
c1c5a070-0e2e-43dd-af9c-a21585200342	Product name	1	20230104
2a463079-cd68-4798-a3d6-55c4c8578d57	Product name	1	20220728
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
652f8f6b-479d-477c-848a-374d5b0145b7	Product name	2	20151203
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83457-113-01	HYRIMOZ	3 in 1 CARTON	INJECTION, SOLUTION	3		7
83457-113-01	HYRIMOZ	0.8 mL in 1 SYRINGE	INJECTION, SOLUTION	0.8		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83457-113-01	ML - Milliliter	83457-113	09e90d52-4569-42ce-b0bb-3550a524ac26	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83457-113	HYRIMOZ (ADALIMUMAB-ADAZ) INJECTION, SOLUTION HYRIMOZ (ADALIMUMAB-ADAZ) KIT [CORDAVIS LIMITED]	4	Current NDC, 2 package rows	20240425_3e303a4a-980b-4f2a-9d03-786928758637.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FYS6T7F842	ADALIMUMAB	331731-18-1	ADALIMUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL 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]	BPCK	3e303a4a-980b-4f2a-9d03-786928758637	7
2641665	{3 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]) } Pack [Hyrimoz Crohn's and UC Starter Kit]	BPCK	3e303a4a-980b-4f2a-9d03-786928758637	7
2641670	{2 (0.4 ML adalimumab-adaz 100 MG/ML Auto-Injector) / 1 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector) } Pack	GPCK	3e303a4a-980b-4f2a-9d03-786928758637	7
2641664	{3 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector) } Pack	GPCK	3e303a4a-980b-4f2a-9d03-786928758637	7
2641653	adalimumab-adaz 20 MG in 0.2 ML Prefilled Syringe	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641655	adalimumab-adaz 40 MG in 0.4 ML Auto-Injector	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641660	adalimumab-adaz 40 MG in 0.4 ML Prefilled Syringe	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2665419	adalimumab-adaz 40 MG in 0.8 ML Auto-Injector	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2665424	adalimumab-adaz 40 MG in 0.8 ML Prefilled Syringe	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641662	adalimumab-adaz 80 MG in 0.8 ML Auto-Injector	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641664	adalimumab-adaz Crohn's and UC or Hidradenitis Suppurativa Starter Pack	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641670	adalimumab-adaz Plaque Psoriasis or Uveitis Starter Kit	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641654	Hyrimoz 20 MG in 0.2 ML Prefilled Syringe	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641658	Hyrimoz 40 MG in 0.4 ML Auto-Injector	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641661	Hyrimoz 40 MG in 0.4 ML Prefilled Syringe	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2665422	Hyrimoz 40 MG in 0.8 ML Auto-Injector	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2665426	Hyrimoz 40 MG in 0.8 ML Prefilled Syringe	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641663	Hyrimoz 80 MG in 0.8 ML Auto-Injector	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641665	Hyrimoz Crohn's and UC or Hidradenitis Suppurativa Starter Kit	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641671	Hyrimoz Plaque Psoriasis or Uveitis Starter Kit	PSN	3e303a4a-980b-4f2a-9d03-786928758637	7
2641654	0.2 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]	SBD	3e303a4a-980b-4f2a-9d03-786928758637	7
2641658	0.4 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]	SBD	3e303a4a-980b-4f2a-9d03-786928758637	7
2641661	0.4 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]	SBD	3e303a4a-980b-4f2a-9d03-786928758637	7
2641663	0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]	SBD	3e303a4a-980b-4f2a-9d03-786928758637	7
2665422	0.8 ML adalimumab-adaz 50 MG/ML Auto-Injector [Hyrimoz]	SBD	3e303a4a-980b-4f2a-9d03-786928758637	7
2665426	0.8 ML adalimumab-adaz 50 MG/ML Prefilled Syringe [Hyrimoz]	SBD	3e303a4a-980b-4f2a-9d03-786928758637	7
2641653	0.2 ML adalimumab-adaz 100 MG/ML Prefilled Syringe	SCD	3e303a4a-980b-4f2a-9d03-786928758637	7
2641655	0.4 ML adalimumab-adaz 100 MG/ML Auto-Injector	SCD	3e303a4a-980b-4f2a-9d03-786928758637	7
2641660	0.4 ML adalimumab-adaz 100 MG/ML Prefilled Syringe	SCD	3e303a4a-980b-4f2a-9d03-786928758637	7
2641662	0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector	SCD	3e303a4a-980b-4f2a-9d03-786928758637	7
2665419	0.8 ML adalimumab-adaz 50 MG/ML Auto-Injector	SCD	3e303a4a-980b-4f2a-9d03-786928758637	7
2665424	0.8 ML adalimumab-adaz 50 MG/ML Prefilled Syringe	SCD	3e303a4a-980b-4f2a-9d03-786928758637	7
2665422	0.8 ML Hyrimoz 50 MG/ML Auto-Injector	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2665426	0.8 ML Hyrimoz 50 MG/ML Prefilled Syringe	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641653	adalimumab-adaz 20 MG per 0.2 ML Prefilled Syringe	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641655	adalimumab-adaz 40 MG per 0.4 ML Auto-Injector	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641660	adalimumab-adaz 40 MG per 0.4 ML Prefilled Syringe	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2665419	adalimumab-adaz 40 MG per 0.8 ML Auto-Injector	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2665424	adalimumab-adaz 40 MG per 0.8 ML Prefilled Syringe	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641662	adalimumab-adaz 80 MG per 0.8 ML Auto-Injector	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641664	adalimumab-adaz Crohn's and UC or Hidradenitis Suppurativa Starter Pack	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641670	adalimumab-adaz Plaque Psoriasis or Uveitis Starter Kit	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641654	Hyrimoz 20 MG per 0.2 ML Prefilled Syringe	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641658	Hyrimoz 40 MG per 0.4 ML Auto-Injector	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641661	Hyrimoz 40 MG per 0.4 ML Prefilled Syringe	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2665422	Hyrimoz 40 MG per 0.8 ML Auto-Injector	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2665426	Hyrimoz 40 MG per 0.8 ML Prefilled Syringe	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641663	Hyrimoz 80 MG per 0.8 ML Auto-Injector	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641665	Hyrimoz Crohn's and UC or Hidradenitis Suppurativa Starter Kit	SY	3e303a4a-980b-4f2a-9d03-786928758637	7
2641671	Hyrimoz Plaque Psoriasis or Uveitis Starter Kit	SY	3e303a4a-980b-4f2a-9d03-786928758637	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83457-113-01	83457011301	3 SYRINGE in 1 CARTON (83457-113-01) / .8 mL in 1 SYRINGE	3 syringe	2023-12-15	No	No	Historical

HYRIMOZ

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#