AMJEVITA

Product NDC: 55513-410
11-digit product format: 555130410
Labeler code: 55513
Product ID: 55513-410_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: 2023-01-31
Substance: ADALIMUMAB
Active strength: 40 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

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
AMJEVITA	ADALIMUMAB-ATTO	Amgen USA Inc.	b7178e36-6787-45ab-8fee-be59bc6a4aa4	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761024
AMJEVITA	ADALIMUMAB-ATTO	Amgen, Inc	9c44bd5b-4464-40a4-8933-8680950f00f2	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761024 ndc (product): 55513-410
AMJEVITA	ADALIMUMAB-ATTO	Nuvaila Limited	d7862491-2634-4402-b001-dcc1abf8dd58	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761024

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/.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 · 18 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2627711	Internal RxNorm lookup
2627717	Internal RxNorm lookup
2627719	Internal RxNorm lookup
2627722	Internal RxNorm lookup
2627724	Internal RxNorm lookup
2627725	Internal RxNorm lookup
2634478	Internal RxNorm lookup
2634479	Internal RxNorm lookup
2663901	Internal RxNorm lookup
2663904	Internal RxNorm lookup
2663906	Internal RxNorm lookup
2663907	Internal RxNorm lookup
2663908	Internal RxNorm lookup
2663910	Internal RxNorm lookup
2663912	Internal RxNorm lookup
2663913	Internal RxNorm lookup
2663914	Internal RxNorm lookup
2663915	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
9c44bd5b-4464-40a4-8933-8680950f00f2	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
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
55513-410-01	AMJEVITA	0.8 mL in 1 SYRINGE	INJECTION	0.8	35
55513-410-01	AMJEVITA	1 in 1 CARTON	INJECTION	1	35
55513-410-02	AMJEVITA	2 in 1 CARTON	INJECTION	2	35
55513-410-02	AMJEVITA	0.8 mL in 1 SYRINGE	INJECTION	0.8	35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55513-410-01	ML - Milliliter	55513-410	60ed612e-215d-4624-99ea-437c83965815	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55513-410	AMJEVITA (ADALIMUMAB-ATTO) INJECTION [AMGEN INC]	30	Current NDC, 4 package rows	20240905_9c44bd5b-4464-40a4-8933-8680950f00f2.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761024	Amjevita	adalimumab-atto	351(k) Interchangeable	Rx	2026-06-01

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
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
55513-410-01	55513041001	1 SYRINGE in 1 CARTON (55513-410-01) / .8 mL in 1 SYRINGE	1 syringe	2023-01-31	No	No	Current
55513-410-02	55513041002	2 SYRINGE in 1 CARTON (55513-410-02) / .8 mL in 1 SYRINGE	2 syringe	2023-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMJEVITA	Amgen, Inc \| Amgen Manufacturing Limited LLC	2026-06-25	HUMAN PRESCRIPTION DRUG LABEL	36
AMJEVITA	A-S Medication Solutions	2023-04-07	HUMAN PRESCRIPTION DRUG LABEL	1