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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FYS6T7F842	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2641653	Internal RxNorm lookup
2641654	Internal RxNorm lookup
2641655	Internal RxNorm lookup
2641658	Internal RxNorm lookup
2641660	Internal RxNorm lookup
2641661	Internal RxNorm lookup
2641662	Internal RxNorm lookup
2641663	Internal RxNorm lookup
2641664	Internal RxNorm lookup
2641665	Internal RxNorm lookup
2641670	Internal RxNorm lookup
2641671	Internal RxNorm lookup
2665419	Internal RxNorm lookup
2665422	Internal RxNorm lookup
2665424	Internal RxNorm lookup
2665426	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3e303a4a-980b-4f2a-9d03-786928758637	Available on FDA.report

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

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adalimumab	ADALIMUMAB-ADAZ	Sandoz Inc	3468792f-63ef-4916-8ed1-8214f327d9dd	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761071
HYRIMOZ	ADALIMUMAB-ADAZ	Cordavis Limited	3e303a4a-980b-4f2a-9d03-786928758637	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761071 ndc (product): 83457-113
HYRIMOZ	ADALIMUMAB-ADAZ	Sandoz Inc	1ac7d061-3380-468c-b077-c05f8dfbc829	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761071

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761071	Hyrimoz	adalimumab-adaz	351(k) Interchangeable	Rx	2026-07-01

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	Current