Adalimumab-adbm

Product NDC: 0597-0555
11-digit product format: 005970555
Labeler code: 0597
Product ID: 0597-0555_0d5e7bae-4147-49a4-8dd6-7763e9402614
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Adalimumab-adbm
Dosage form: KIT
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: BLA761058
Marketing category: BLA
Marketing start: 2023-10-01
NDC exclude flag: No
Listing certified through: 2026-12-31
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
Cyltezo	ADALIMUMAB-ADBM	Boehringer Ingelheim Pharmaceuticals, Inc.	115ea79b-7209-7f19-b35d-36ec0828fbf5	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761058
Adalimumab-adbm	ADALIMUMAB-ADBM	Boehringer Ingelheim Pharmaceuticals, Inc.	62f39a7c-00df-4519-a8d4-39bbd0a649ed	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761058 ndc (product): 0597-0555
Adalimumab-adbm	ADALIMUMAB-ADBM	QUALLENT PHARMACEUTICALS HEALTH LLC	f9986706-9c75-4335-a54f-09d7716dbcef	2024-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761058

Additional Listing Data#

Finished product: Yes
Brand name base: Adalimumab-adbm
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
797544	Internal RxNorm lookup
2640883	Internal RxNorm lookup
2640891	Internal RxNorm lookup
2640893	Internal RxNorm lookup
2640895	Internal RxNorm lookup
2640900	Internal RxNorm lookup
2640902	Internal RxNorm lookup
2680743	Internal RxNorm lookup
2680748	Internal RxNorm lookup
2680756	Internal RxNorm lookup
2680759	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
62f39a7c-00df-4519-a8d4-39bbd0a649ed	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
652f8f6b-479d-477c-848a-374d5b0145b7	Product name	2	20151203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0597-0550-06	Adalimumab-adbm	1 in 1 TRAY	INJECTION, SOLUTION		20 mg in 0.4mL	5
0597-0550-06	Adalimumab-adbm	0.4 mL in 1 SYRINGE	INJECTION, SOLUTION	0.4 mL	20 mg in 0.4mL	5
0597-0555-80	Adalimumab-adbm	1 in 1 KIT	KIT	1		5
0597-0555-80	Adalimumab-adbm	2 in 1 CARTON	KIT	2		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0555-80	EA - Each	0597-0555	ad5aa881-8cb1-4b39-a293-c21ccc22be5f	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0597-0555	ADALIMUMAB-ADBM KIT [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2	Current NDC, 4 package rows	20240507_62f39a7c-00df-4519-a8d4-39bbd0a649ed.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761058	Cyltezo	adalimumab-adbm	351(k) Interchangeable	Rx	2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2680756	{4 (0.4 ML adalimumab-adbm 100 MG/ML Auto-Injector) } Pack	GPCK	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640900	{4 (0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector) } Pack	GPCK	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2680759	{6 (0.4 ML adalimumab-adbm 100 MG/ML Auto-Injector) } Pack	GPCK	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640902	{6 (0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector) } Pack	GPCK	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640891	adalimumab-adbm 10 MG in 0.2 ML Prefilled Syringe	PSN	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640893	adalimumab-adbm 20 MG in 0.4 ML Prefilled Syringe	PSN	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2680748	adalimumab-adbm 40 MG in 0.4 ML Auto-Injector	PSN	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2680743	adalimumab-adbm 40 MG in 0.4 ML Prefilled Syringe	PSN	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640895	adalimumab-adbm 40 MG in 0.8 ML Auto-Injector	PSN	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640883	adalimumab-adbm 40 MG in 0.8 ML Prefilled Syringe	PSN	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2680759	adalimumab-adbm Pen 40 MG/0.4 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)	PSN	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2680756	adalimumab-adbm Pen 40 MG/0.4 ML Starter Pack - Psoriasis/Uveitis (4 count)	PSN	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640902	adalimumab-adbm Pen 40 MG/0.8 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)	PSN	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640900	adalimumab-adbm Pen 40 MG/0.8 ML Starter Pack - Psoriasis/Uveitis (4 count)	PSN	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
797544	isopropyl alcohol 70 % Medicated Pad	PSN	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640891	0.2 ML adalimumab-adbm 50 MG/ML Prefilled Syringe	SCD	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2680748	0.4 ML adalimumab-adbm 100 MG/ML Auto-Injector	SCD	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2680743	0.4 ML adalimumab-adbm 100 MG/ML Prefilled Syringe	SCD	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640893	0.4 ML adalimumab-adbm 50 MG/ML Prefilled Syringe	SCD	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640895	0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector	SCD	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640883	0.8 ML adalimumab-adbm 50 MG/ML Prefilled Syringe	SCD	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640891	adalimumab-adbm 10 MG per 0.2 ML Prefilled Syringe	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640893	adalimumab-adbm 20 MG per 0.4 ML Prefilled Syringe	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2680748	adalimumab-adbm 40 MG per 0.4 ML Auto-Injector	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2680743	adalimumab-adbm 40 MG per 0.4 ML Prefilled Syringe	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640895	adalimumab-adbm 40 MG per 0.8 ML Auto-Injector	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640883	adalimumab-adbm 40 MG per 0.8 ML Prefilled Syringe	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2680759	adalimumab-adbm Pen 40 MG/0.4 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2680756	adalimumab-adbm Pen 40 MG/0.4 ML Starter Pack - Psoriasis/Uveitis (4 count)	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640902	adalimumab-adbm Pen 40 MG/0.8 ML - Starter Pack for Crohn's Disease, Ulcerative Colitis or Hidradenitis Suppurativa (6 count)	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
2640900	adalimumab-adbm Pen 40 MG/0.8 ML Starter Pack - Psoriasis/Uveitis (4 count)	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
797544	isopropyl alcohol 70 % Medicated Pad	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
797544	isopropyl alcohol 70 % Topical Cloth	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5
797544	isopropyl alcohol 70 % Topical Swab	SY	62f39a7c-00df-4519-a8d4-39bbd0a649ed	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0597-0550-06	00597055006	1 in 1 TRAY					Historical
0597-0555-80	00597055580	2 KIT in 1 CARTON (0597-0555-80) / 1 KIT in 1 KIT * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET * 1 SYRINGE in 1 TRAY (0597-0550-06) / .4 mL in 1 SYRINGE	2 kit	2023-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adalimumab-adbm	Boehringer Ingelheim Pharmaceuticals, Inc.	2025-11-12	HUMAN PRESCRIPTION DRUG LABEL	5