Home NDC 57894-160 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 Ingredient Strength INFLIXIMAB 100 mg/10mL
Harmonized Identifiers# Field, Values table Field Values Unii B72HH48FLU Rxcui 310994
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57894-160-01 INFLIXIMAB 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 5 57894-160-01 INFLIXIMAB 10 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57894-160 INFLIXIMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20250313_b05c174f-832c-4321-b34f-2c4ad3742269.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57894-160-01 57894016001 1 VIAL, SINGLE-USE in 1 BOX (57894-160-01) / 10 mL in 1 VIAL, SINGLE-USE 2021-10-05 0000-00-00 No No Current