darzalex

Generic: daratumumab

Labeler: janssen biotech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name darzalex
Generic Name daratumumab
Labeler janssen biotech, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

daratumumab 100 mg/5mL

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-502
Product ID 57894-502_7a931e23-16ed-4112-a593-6c1a696cd4aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761036
Listing Expiration 2027-12-31
Marketing Start 2015-11-16

Pharmacologic Class

Established (EPC)
cd38-directed cytolytic antibody [epc]
Mechanism of Action
cd38-directed antibody interactions [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894502
Hyphenated Format 57894-502

Supplemental Identifiers

RxCUI
1721951 1721956 1726439 1726440
UPC
0357894502050
UNII
4Z63YK6E0E
NUI
N0000192336 N0000192335 M0001357

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name darzalex (source: ndc)
Generic Name daratumumab (source: ndc)
Application Number BLA761036 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (57894-502-05) / 5 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (57894-502-20) / 20 mL in 1 VIAL
source: ndc

Packages (2)

57894-502-05 1 VIAL in 1 CARTON (57894-502-05) / 5 mL in 1 VIAL 57894-502-20 1 VIAL in 1 CARTON (57894-502-20) / 20 mL in 1 VIAL

Ingredients (1)

daratumumab (100 mg/5mL)

Linked Drug Pages (1)

DARZALEX, Darzalex IV ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7a931e23-16ed-4112-a593-6c1a696cd4aa", "openfda": {"nui": ["N0000192336", "N0000192335", "M0001357"], "upc": ["0357894502050"], "unii": ["4Z63YK6E0E"], "rxcui": ["1721951", "1721956", "1726439", "1726440"], "spl_set_id": ["a4d0efe9-5e54-467e-9eb4-56fa7d53b60b"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["CD38-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD38-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (57894-502-05)  / 5 mL in 1 VIAL", "package_ndc": "57894-502-05", "marketing_end_date": "20261031", "marketing_start_date": "20151116"}, {"sample": false, "description": "1 VIAL in 1 CARTON (57894-502-20)  / 20 mL in 1 VIAL", "package_ndc": "57894-502-20", "marketing_end_date": "20261130", "marketing_start_date": "20151116"}], "brand_name": "DARZALEX", "product_id": "57894-502_7a931e23-16ed-4112-a593-6c1a696cd4aa", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Antibodies", "Monoclonal [CS]", "CD38-directed Antibody Interactions [MoA]", "CD38-directed Cytolytic Antibody [EPC]"], "product_ndc": "57894-502", "generic_name": "Daratumumab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DARZALEX", "active_ingredients": [{"name": "DARATUMUMAB", "strength": "100 mg/5mL"}], "application_number": "BLA761036", "marketing_category": "BLA", "marketing_start_date": "20151116", "listing_expiration_date": "20271231"}