ABRILADA

Product NDC: 0025-0328
11-digit product format: 000250328
Labeler code: 0025
Product ID: 0025-0328_0989d777-c225-46a6-854e-01bdf4f19679
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: adalimumab-afzb
Dosage form: KIT
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: BLA761118
Marketing category: BLA
Marketing start: 2023-12-14
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0025-0328	0025-0328-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

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

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
2668064	Internal RxNorm lookup
2668071	Internal RxNorm lookup
2668074	Internal RxNorm lookup
2668078	Internal RxNorm lookup
2668095	Internal RxNorm lookup
2668096	Internal RxNorm lookup
2668105	Internal RxNorm lookup
2668106	Internal RxNorm lookup
2668109	Internal RxNorm lookup
2668113	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
5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0025-0317-01	ABRILADA	0.8 mL in 1 SYRINGE	INJECTION, SOLUTION	0.8 mL	40 mg in 0.8mL	8
0025-0328-01	ABRILADA	1 in 1 KIT	KIT	1		8
0025-0328-01	ABRILADA	1 in 1 CARTON	KIT	1		8
0025-0328-02	ABRILADA	1 in 1 KIT	KIT	1		8
0025-0328-02	ABRILADA	2 in 1 CARTON	KIT	2		8
0069-1111-01	ABRILADA	1 mL in 1 PACKET	SWAB	1 mL	70 mL in 100mL	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0025-0328-02	EA - Each	0025-0328	26ad1c68-cafb-4424-8736-5271f123b548	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0025-0328	ABRILADA (ADALIMUMAB-AFZB) KIT ABRILADA (ADALIMUMAB-AFZB) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]	5	Current NDC, 6 package rows	20250116_5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f.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
ABRILADA	ADALIMUMAB-AFZB	A-S Medication Solutions	1602cfaf-9ddd-4eb6-b847-10a4eebcf5e5	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761118
ABRILADA	ADALIMUMAB-AFZB	A-S Medication Solutions	79943fe6-1249-4074-9aed-c53937820d0f	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761118
ABRILADA	ADALIMUMAB-AFZB	Pfizer Laboratories Div Pfizer Inc	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761118 ndc (product): 0025-0328

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761118	Abrilada	adalimumab-afzb	351(k) Interchangeable	Rx	2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2668106	Abrilada 10 MG in 0.2 ML Prefilled Syringe	PSN	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668096	Abrilada 20 MG in 0.4 ML Prefilled Syringe	PSN	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668071	Abrilada 40 MG in 0.8 ML Auto-Injector	PSN	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668113	Abrilada 40 MG in 0.8 ML Injection	PSN	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668078	Abrilada 40 MG in 0.8 ML Prefilled Syringe	PSN	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668105	adalimumab-afzb 10 MG in 0.2 ML Prefilled Syringe	PSN	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668095	adalimumab-afzb 20 MG in 0.4 ML Prefilled Syringe	PSN	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668064	adalimumab-afzb 40 MG in 0.8 ML Auto-Injector	PSN	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668109	adalimumab-afzb 40 MG in 0.8 ML Injection	PSN	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668074	adalimumab-afzb 40 MG in 0.8 ML Prefilled Syringe	PSN	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
797544	isopropyl alcohol 70 % Medicated Pad	PSN	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668106	0.2 ML adalimumab-afzb 50 MG/ML Prefilled Syringe [Abrilada]	SBD	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668096	0.4 ML adalimumab-afzb 50 MG/ML Prefilled Syringe [Abrilada]	SBD	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668071	0.8 ML adalimumab-afzb 50 MG/ML Auto-Injector [Abrilada]	SBD	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668113	0.8 ML adalimumab-afzb 50 MG/ML Injection [Abrilada]	SBD	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668078	0.8 ML adalimumab-afzb 50 MG/ML Prefilled Syringe [Abrilada]	SBD	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668105	0.2 ML adalimumab-afzb 50 MG/ML Prefilled Syringe	SCD	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668095	0.4 ML adalimumab-afzb 50 MG/ML Prefilled Syringe	SCD	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668064	0.8 ML adalimumab-afzb 50 MG/ML Auto-Injector	SCD	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668109	0.8 ML adalimumab-afzb 50 MG/ML Injection	SCD	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668074	0.8 ML adalimumab-afzb 50 MG/ML Prefilled Syringe	SCD	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668106	Abrilada 10 MG per 0.2 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668096	Abrilada 20 MG per 0.4 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668071	Abrilada 40 MG per 0.8 ML Auto-Injector	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668113	Abrilada 40 MG per 0.8 ML Injection	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668078	Abrilada 40 MG per 0.8 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668106	Abrilada 50 MG/ML per 0.2 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668096	Abrilada 50 MG/ML per 0.4 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668071	Abrilada 50 MG/ML per 0.8 ML Auto-Injector	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668113	Abrilada 50 MG/ML per 0.8 ML Injection	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668078	Abrilada 50 MG/ML per 0.8 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668105	adalimumab-afzb 10 MG per 0.2 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668095	adalimumab-afzb 20 MG per 0.4 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668064	adalimumab-afzb 40 MG per 0.8 ML Auto-Injector	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668109	adalimumab-afzb 40 MG per 0.8 ML Injection	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668074	adalimumab-afzb 40 MG per 0.8 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668105	adalimumab-afzb 50 MG/ML per 0.2 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668095	adalimumab-afzb 50 MG/ML per 0.4 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668064	adalimumab-afzb 50 MG/ML per 0.8 ML Auto-Injector	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668109	adalimumab-afzb 50 MG/ML per 0.8 ML Injection	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
2668074	adalimumab-afzb 50 MG/ML per 0.8 ML Prefilled Syringe	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
797544	isopropyl alcohol 70 % Medicated Pad	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
797544	isopropyl alcohol 70 % Topical Cloth	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8
797544	isopropyl alcohol 70 % Topical Swab	SY	5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0025-0317-01	00025031701	0.8 mL in 1 SYRINGE	0.8 ml				Historical
0025-0328-01	00025032801	1 in 1 KIT					Historical
0025-0328-02	00025032802	2 KIT in 1 CARTON (0025-0328-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (0025-0317-01) * 1 mL in 1 PACKET (0069-1111-01)	2 kit	2023-12-14	No	No	Current
0069-1111-01	00069111101	1 mL in 1 PACKET	1 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ABRILADA	A-S Medication Solutions	2026-08-07	HUMAN PRESCRIPTION DRUG LABEL	1
ABRILADA	Pfizer Laboratories Div Pfizer Inc \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Belgium NV	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	8