HYRIMOZ

Product NDC: 61314-531
11-digit product format: 613140531
Labeler code: 61314
Product ID: 61314-531_af358c91-4472-4fb1-87ba-001d67f2b4f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: adalimumab-adaz
Dosage form: KIT
Labeler: Sandoz Inc
Application: BLA761071
Marketing category: BLA
Marketing start: 2023-07-01
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
HYRIMOZ	ADALIMUMAB-ADAZ	Sandoz Inc	1ac7d061-3380-468c-b077-c05f8dfbc829	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761071 ndc (product): 61314-531

Additional Listing Data#

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

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 · 20 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2641644	Internal RxNorm lookup
2641650	Internal RxNorm lookup
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
2641666	Internal RxNorm lookup
2641667	Internal RxNorm lookup
2641668	Internal RxNorm lookup
2641669	Internal RxNorm lookup
2641670	Internal RxNorm lookup
2641671	Internal RxNorm lookup
2641672	Internal RxNorm lookup
2641673	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
1ac7d061-3380-468c-b077-c05f8dfbc829	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
61314-531-64	HYRIMOZ	1 in 1 KIT	KIT	1		13
61314-531-64	HYRIMOZ	2 in 1 CARTON	KIT	2		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-531-64	ML - Milliliter	61314-531	be74fd06-4a02-4a36-bb52-7872b3e51a7c	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-531	HYRIMOZ (ADALIMUMAB-ADAZ) INJECTION, SOLUTION HYRIMOZ (ADALIMUMAB-ADAZ) KIT [SANDOZ INC]	7	Current NDC, 2 package rows	20240426_1ac7d061-3380-468c-b077-c05f8dfbc829.zip

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	2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL 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]	BPCK	1ac7d061-3380-468c-b077-c05f8dfbc829	13
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	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641665	{3 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]) } Pack [Hyrimoz Crohn's and UC Starter Kit]	BPCK	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641669	{3 (0.8 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]) } Pack [Hyrimoz Pediatric Crohn's Starter Kit Patient Weight > 40 KG]	BPCK	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641672	{1 (0.4 ML adalimumab-adaz 100 MG/ML Prefilled Syringe) / 1 (0.8 ML adalimumab-adaz 100 MG/ML Prefilled Syringe) } Pack	GPCK	1ac7d061-3380-468c-b077-c05f8dfbc829	13
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	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641664	{3 (0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector) } Pack	GPCK	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641668	{3 (0.8 ML adalimumab-adaz 100 MG/ML Prefilled Syringe) } Pack	GPCK	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641644	adalimumab-adaz 10 MG in 0.1 ML Prefilled Syringe	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641653	adalimumab-adaz 20 MG in 0.2 ML Prefilled Syringe	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641655	adalimumab-adaz 40 MG in 0.4 ML Auto-Injector	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641660	adalimumab-adaz 40 MG in 0.4 ML Prefilled Syringe	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641662	adalimumab-adaz 80 MG in 0.8 ML Auto-Injector	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641666	adalimumab-adaz 80 MG in 0.8 ML Prefilled Syringe	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641664	adalimumab-adaz Crohn's and UC or Hidradenitis Suppurativa Starter Pack	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641672	adalimumab-adaz Pediatric Crohn's Starter Kit Patient Weight < 40 KG	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641668	adalimumab-adaz Pediatric Crohn's Starter Kit Patient Weight > 40 KG	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641670	adalimumab-adaz Plaque Psoriasis or Uveitis Starter Kit	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641650	Hyrimoz 10 MG in 0.1 ML Prefilled Syringe	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641654	Hyrimoz 20 MG in 0.2 ML Prefilled Syringe	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641658	Hyrimoz 40 MG in 0.4 ML Auto-Injector	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641661	Hyrimoz 40 MG in 0.4 ML Prefilled Syringe	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641663	Hyrimoz 80 MG in 0.8 ML Auto-Injector	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641667	Hyrimoz 80 MG in 0.8 ML Prefilled Syringe	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641665	Hyrimoz Crohn's and UC or Hidradenitis Suppurativa Starter Kit	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641673	Hyrimoz Pediatric Crohn's Starter Kit Patient Weight < 40 KG	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641669	Hyrimoz Pediatric Crohn's Starter Kit Patient Weight > 40 KG	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641671	Hyrimoz Plaque Psoriasis or Uveitis Starter Kit	PSN	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641650	0.1 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]	SBD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641654	0.2 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]	SBD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641658	0.4 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]	SBD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641661	0.4 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]	SBD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641663	0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector [Hyrimoz]	SBD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641667	0.8 ML adalimumab-adaz 100 MG/ML Prefilled Syringe [Hyrimoz]	SBD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641644	0.1 ML adalimumab-adaz 100 MG/ML Prefilled Syringe	SCD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641653	0.2 ML adalimumab-adaz 100 MG/ML Prefilled Syringe	SCD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641655	0.4 ML adalimumab-adaz 100 MG/ML Auto-Injector	SCD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641660	0.4 ML adalimumab-adaz 100 MG/ML Prefilled Syringe	SCD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641662	0.8 ML adalimumab-adaz 100 MG/ML Auto-Injector	SCD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641666	0.8 ML adalimumab-adaz 100 MG/ML Prefilled Syringe	SCD	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641644	adalimumab-adaz 10 MG per 0.1 ML Prefilled Syringe	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641653	adalimumab-adaz 20 MG per 0.2 ML Prefilled Syringe	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641655	adalimumab-adaz 40 MG per 0.4 ML Auto-Injector	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641660	adalimumab-adaz 40 MG per 0.4 ML Prefilled Syringe	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641662	adalimumab-adaz 80 MG per 0.8 ML Auto-Injector	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641666	adalimumab-adaz 80 MG per 0.8 ML Prefilled Syringe	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641664	adalimumab-adaz Crohn's and UC or Hidradenitis Suppurativa Starter Pack	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641672	adalimumab-adaz Pediatric Crohn's Starter Kit Patient Weight < 40 KG	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641668	adalimumab-adaz Pediatric Crohn's Starter Kit Patient Weight > 40 KG	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641670	adalimumab-adaz Plaque Psoriasis or Uveitis Starter Kit	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641650	Hyrimoz 10 MG per 0.1 ML Prefilled Syringe	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641654	Hyrimoz 20 MG per 0.2 ML Prefilled Syringe	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641658	Hyrimoz 40 MG per 0.4 ML Auto-Injector	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641661	Hyrimoz 40 MG per 0.4 ML Prefilled Syringe	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641663	Hyrimoz 80 MG per 0.8 ML Auto-Injector	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641667	Hyrimoz 80 MG per 0.8 ML Prefilled Syringe	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641665	Hyrimoz Crohn's and UC or Hidradenitis Suppurativa Starter Kit	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641673	Hyrimoz Pediatric Crohn's Starter Kit Patient Weight < 40 KG	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641669	Hyrimoz Pediatric Crohn's Starter Kit Patient Weight > 40 KG	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13
2641671	Hyrimoz Plaque Psoriasis or Uveitis Starter Kit	SY	1ac7d061-3380-468c-b077-c05f8dfbc829	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61314-531-64	61314053164	2 KIT in 1 CARTON (61314-531-64) / 1 KIT in 1 KIT * 1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS * 1 SYRINGE, GLASS in 1 CARTON / .4 mL in 1 SYRINGE, GLASS	2 kit	2023-07-01	No	No	Current