Home NDC 57894-502-05 DARZALEX
Product NDC 57894-502
Requested package NDC 57894-502-05
11-digit product format 578940502
Labeler code 57894
Product ID 57894-502_7a931e23-16ed-4112-a593-6c1a696cd4aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Daratumumab
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Janssen Biotech, Inc.
Application BLA761036
Marketing category BLA
Marketing start 2015-11-16
Substance DARATUMUMAB
Active strength 100 mg/5mL
Pharmacologic classes Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base DARZALEX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DARATUMUMAB 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Z63YK6E0E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1721951 Internal RxNorm lookup 1721956 Internal RxNorm lookup 1726439 Internal RxNorm lookup 1726440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 57894-502-05 2021-09-10 These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 57894-502-05 2021-09-10 These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 57894-502-20 2021-09-10 These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 57894-502-20 2021-09-10 These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 57894-502-05 2021-07-23 These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 57894-502-05 2021-07-23 These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 57894-502-20 2021-07-23 These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015 57894-502-20 2021-07-23 These highlights do not include all the information needed to use DARZALEX safely and effectively. See full prescribing information for DARZALEX. DARZALEX ® (daratumumab) injection, for intravenous use Initial U.S. Approval: 2015
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57894-502-05 DARZALEX 5 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 5 43 57894-502-05 DARZALEX 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 43 57894-502-20 DARZALEX 20 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 20 43 57894-502-20 DARZALEX 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 43
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Daratumumab ACTIVE INGREDIENT 4Z63YK6E0E DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] 2 Daratumumab ACTIVE MOIETY 4Z63YK6E0E DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] 2 mannitol INACTIVE INGREDIENT 3OWL53L36A DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] 2 polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] 2 sodium acetate INACTIVE INGREDIENT 4550K0SC9B DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] 2 sodium chloride INACTIVE INGREDIENT 451W47IQ8X DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57894-502 DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE DARZALEX IV (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] 40 Current NDC, Legacy NDC, 4 package rows 20250417_a4d0efe9-5e54-467e-9eb4-56fa7d53b60b.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 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761036 Darzalex daratumumab 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57894-502-05 57894050205 1 VIAL in 1 CARTON (57894-502-05) / 5 mL in 1 VIAL 1 vial 2015-11-16 2026-10-31 No No Current