AMJEVITA

Product NDC: 55513-482
11-digit product format: 555130482
Labeler code: 55513
Product ID: 55513-482_4c9ab922-684f-4715-a32b-c5e0c5261af7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: adalimumab-atto
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Amgen, Inc
Application: BLA761024
Marketing category: BLA
Marketing start: 2023-08-14
Substance: ADALIMUMAB
Active strength: 40 mg/.4mL
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: AMJEVITA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ADALIMUMAB	40 mg/.4mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	FYS6T7F842
Rxcui	2627711, 2627717, 2627719, 2627722, 2627724, 2627725, 2634478, 2634479, 2663901, 2663904, 2663906, 2663907, 2663908, 2663910, 2663912, 2663913, 2663914, 2663915

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
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
652f8f6b-479d-477c-848a-374d5b0145b7	Product name	2	20151203
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55513-482-01	AMJEVITA	0.4 mL in 1 SYRINGE	INJECTION	0.4	35
55513-482-01	AMJEVITA	1 in 1 CARTON	INJECTION	1	35
55513-482-02	AMJEVITA	0.4 mL in 1 SYRINGE	INJECTION	0.4	35
55513-482-02	AMJEVITA	2 in 1 CARTON	INJECTION	2	35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55513-482	AMJEVITA (ADALIMUMAB-ATTO) INJECTION [AMGEN INC]	30	Current NDC, 4 package rows	20240905_9c44bd5b-4464-40a4-8933-8680950f00f2.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
2634478	adalimumab-atto 10 MG in 0.2 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663901	adalimumab-atto 20 MG in 0.2 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627711	adalimumab-atto 20 MG in 0.4 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663908	adalimumab-atto 40 MG in 0.4 ML Auto-Injector	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663906	adalimumab-atto 40 MG in 0.4 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627719	adalimumab-atto 40 MG in 0.8 ML Auto-Injector	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627724	adalimumab-atto 40 MG in 0.8 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663914	adalimumab-atto 80 MG in 0.8 ML Auto-Injector	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663912	adalimumab-atto 80 MG in 0.8 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2634479	AMJEVITA 10 MG in 0.2 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663904	AMJEVITA 20 MG in 0.2 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627717	AMJEVITA 20 MG in 0.4 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663910	AMJEVITA 40 MG in 0.4 ML Auto-Injector	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663907	AMJEVITA 40 MG in 0.4 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627722	AMJEVITA 40 MG in 0.8 ML Auto-Injector	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627725	AMJEVITA 40 MG in 0.8 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663915	AMJEVITA 80 MG in 0.8 ML Auto-Injector	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663913	AMJEVITA 80 MG in 0.8 ML Prefilled Syringe	PSN	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663904	0.2 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]	SBD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2634479	0.2 ML adalimumab-atto 50 MG/ML Prefilled Syringe [Amjevita]	SBD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663910	0.4 ML adalimumab-atto 100 MG/ML Auto-Injector [Amjevita]	SBD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663907	0.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]	SBD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627717	0.4 ML adalimumab-atto 50 MG/ML Prefilled Syringe [Amjevita]	SBD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663915	0.8 ML adalimumab-atto 100 MG/ML Auto-Injector [Amjevita]	SBD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663913	0.8 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]	SBD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627722	0.8 ML adalimumab-atto 50 MG/ML Auto-Injector [Amjevita]	SBD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627725	0.8 ML adalimumab-atto 50 MG/ML Prefilled Syringe [Amjevita]	SBD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663901	0.2 ML adalimumab-atto 100 MG/ML Prefilled Syringe	SCD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2634478	0.2 ML adalimumab-atto 50 MG/ML Prefilled Syringe	SCD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663908	0.4 ML adalimumab-atto 100 MG/ML Auto-Injector	SCD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663906	0.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe	SCD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627711	0.4 ML adalimumab-atto 50 MG/ML Prefilled Syringe	SCD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663914	0.8 ML adalimumab-atto 100 MG/ML Auto-Injector	SCD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663912	0.8 ML adalimumab-atto 100 MG/ML Prefilled Syringe	SCD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627719	0.8 ML adalimumab-atto 50 MG/ML Auto-Injector	SCD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627724	0.8 ML adalimumab-atto 50 MG/ML Prefilled Syringe	SCD	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627717	0.4 ML Amjevita 50 MG/ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627722	0.8 ML Amjevita 50 MG/ML Auto-Injector	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627725	0.8 ML Amjevita 50 MG/ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2634478	adalimumab-atto 10 MG per 0.2 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663901	adalimumab-atto 20 MG per 0.2 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627711	adalimumab-atto 20 MG per 0.4 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663908	adalimumab-atto 40 MG per 0.4 ML Auto-Injector	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663906	adalimumab-atto 40 MG per 0.4 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627719	adalimumab-atto 40 MG per 0.8 ML Auto-Injector	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627724	adalimumab-atto 40 MG per 0.8 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2634478	adalimumab-atto 50 MG/ML per 0.2 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663914	adalimumab-atto 80 MG per 0.8 ML Auto-Injector	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663912	adalimumab-atto 80 MG per 0.8 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2634479	Amjevita 10 MG per 0.2 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663904	Amjevita 20 MG per 0.2 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627717	Amjevita 20 MG per 0.4 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663910	Amjevita 40 MG per 0.4 ML Auto-Injector	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663907	Amjevita 40 MG per 0.4 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627722	Amjevita 40 MG per 0.8 ML Auto-Injector	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2627725	Amjevita 40 MG per 0.8 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2634479	Amjevita 50 MG/ML per 0.2 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663915	Amjevita 80 MG per 0.8 ML Auto-Injector	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35
2663913	Amjevita 80 MG per 0.8 ML Prefilled Syringe	SY	9c44bd5b-4464-40a4-8933-8680950f00f2	35

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55513-482-01	55513048201	1 SYRINGE in 1 CARTON (55513-482-01) / .4 mL in 1 SYRINGE	1 syringe	2023-08-14	No	No	Current
55513-482-02	55513048202	2 SYRINGE in 1 CARTON (55513-482-02) / .4 mL in 1 SYRINGE	2 syringe	2023-08-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMJEVITA	Amgen, Inc \| Amgen Manufacturing Limited LLC \| Bioreliance Corporation	2026-03-10	HUMAN PRESCRIPTION DRUG LABEL	35

AMJEVITA

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#