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

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

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
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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103772Remicadeinfliximab351(a)Rx2026-07-01

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