Home NDC 57894-030 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 Identifiers# Field, Values table Field Values Unii B72HH48FLU Rxcui 213361, 310994
DailyMed Product Concepts# 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 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
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 57894-030-01 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