REMICADE

Product NDC: 57894-030
11-digit product format: 578940030
Labeler code: 57894
Product ID: 57894-030_36afec96-dd29-9328-e063-6294a90af8e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: INFLIXIMAB
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Janssen Biotech, Inc.
Application: BLA103772
Marketing category: BLA
Marketing start: 1998-08-24
Substance: INFLIXIMAB
Active strength: 100 mg/10mL
Pharmacologic classes: Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INFLIXIMAB	100 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B72HH48FLU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
213361	Internal RxNorm lookup
310994	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
a0a046c1-056d-45a9-bfd9-13b47c24f257	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fd7a994a-5706-4fb6-ad0f-bf950de5c161	Product name	1	20250721
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
6e0fa83e-7840-4808-ae8f-3478d418847b	Product name	1	20230703
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57894-030-01	REMICADE	10 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	10		37
57894-030-01	REMICADE	1 in 1 BOX	INJECTION, POWDER, LYOPHILIZED,	1		37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57894-030-01	EA - Each	57894-030	82b26a35-5c22-4d96-8cf7-c8948283c217	1	2012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57894-030	REMICADE (INFLIXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.]	36	Current NDC, Legacy NDC, 2 package rows	20250309_a0a046c1-056d-45a9-bfd9-13b47c24f257.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFLIXIMAB	INFLIXIMAB	Janssen Biotech, Inc.	b05c174f-832c-4321-b34f-2c4ad3742269	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA103772
REMICADE	INFLIXIMAB	Janssen Biotech, Inc.	a0a046c1-056d-45a9-bfd9-13b47c24f257	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA103772 ndc (product): 57894-030

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103772	Remicade	infliximab	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B72HH48FLU	INFLIXIMAB	170277-31-3	INFLIXIMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310994	inFLIXimab 100 MG Injection	PSN	a0a046c1-056d-45a9-bfd9-13b47c24f257	37
213361	Remicade 100 MG Injection	PSN	a0a046c1-056d-45a9-bfd9-13b47c24f257	37
213361	infliximab 100 MG Injection [Remicade]	SBD	a0a046c1-056d-45a9-bfd9-13b47c24f257	37
310994	infliximab 100 MG Injection	SCD	a0a046c1-056d-45a9-bfd9-13b47c24f257	37
310994	infliximab 100 MG per 10 ML Injection	SY	a0a046c1-056d-45a9-bfd9-13b47c24f257	37
213361	Remicade 100 MG Injection	SY	a0a046c1-056d-45a9-bfd9-13b47c24f257	37
213361	Remicade 100 MG per 10 ML Injection	SY	a0a046c1-056d-45a9-bfd9-13b47c24f257	37

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57894-030-01	57894003001	1 VIAL, SINGLE-USE in 1 BOX (57894-030-01) / 10 mL in 1 VIAL, SINGLE-USE	1998-08-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
REMICADE	Janssen Biotech, Inc. \| Hospira, Inc. \| AndersonBrecon Inc. \| Patheon Italia S.p.A. \| Janssen Biologics B.V. \| Cilag AG \| Janssen-Cilag Manufacturing, LLC	2025-06-03	HUMAN PRESCRIPTION DRUG LABEL	37