FDA.reportPublic FDA data

INFLIXIMAB

Product NDC
57894-160
11-digit product format
578940160
Labeler code
57894
Product ID
57894-160_3bfeaa57-8d95-4bc9-8bb5-274271688470
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
2021-10-05
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
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFLIXIMABINFLIXIMABJanssen Biotech, Inc.b05c174f-832c-4321-b34f-2c4ad37422692026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103772
ndc (product): 57894-160
REMICADEINFLIXIMABJanssen Biotech, Inc.a0a046c1-056d-45a9-bfd9-13b47c24f2572025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103772

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INFLIXIMAB100 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B72HH48FLUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310994Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b05c174f-832c-4321-b34f-2c4ad3742269Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd7a994a-5706-4fb6-ad0f-bf950de5c161Product name120250721
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
6e0fa83e-7840-4808-ae8f-3478d418847bProduct name120230703
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57894-160-01INFLIXIMAB1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,15
57894-160-01INFLIXIMAB10 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-160-01EA - Each57894-1606c16a86b-0349-42b4-a08a-c9ce8f12c35212021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-160INFLIXIMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.]3Current NDC, Legacy NDC, 2 package rows20250313_b05c174f-832c-4321-b34f-2c4ad3742269.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103772Remicadeinfliximab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310994inFLIXimab 100 MG InjectionPSNb05c174f-832c-4321-b34f-2c4ad37422695
310994infliximab 100 MG InjectionSCDb05c174f-832c-4321-b34f-2c4ad37422695
310994infliximab 100 MG per 10 ML InjectionSYb05c174f-832c-4321-b34f-2c4ad37422695

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57894-160-01578940160011 VIAL, SINGLE-USE in 1 BOX (57894-160-01) / 10 mL in 1 VIAL, SINGLE-USE2021-10-050000-00-00NoNoCurrent