darzalex faspro

Generic: daratumumab and hyaluronidase-fihj (human recombinant)

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

Drug Facts

Product Profile

Brand Name darzalex faspro
Generic Name daratumumab and hyaluronidase-fihj (human recombinant)
Labeler janssen biotech, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

daratumumab 1800 mg/15mL, hyaluronidase (human recombinant) 30000 U/15mL

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-503
Product ID 57894-503_8cd9a8a9-e03e-4557-8b3b-c9d280024acf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761145
Listing Expiration 2027-12-31
Marketing Start 2020-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894503
Hyphenated Format 57894-503

Supplemental Identifiers

RxCUI
2375136 2375141
UPC
0357894503019
UNII
4Z63YK6E0E 743QUY4VD8
NUI
N0000192336 N0000192335 M0001357 N0000175531 M0009499

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 faspro (source: ndc)
Generic Name daratumumab and hyaluronidase-fihj (human recombinant) (source: ndc)
Application Number BLA761145 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1800 mg/15mL
  • 30000 U/15mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) / 15 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

57894-503-01 1 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) / 15 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

daratumumab (1800 mg/15mL) hyaluronidase (human recombinant) (30000 U/15mL)

Linked Drug Pages (1)

Darzalex Faspro ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "8cd9a8a9-e03e-4557-8b3b-c9d280024acf", "openfda": {"nui": ["N0000192336", "N0000192335", "M0001357", "N0000175531", "M0009499"], "upc": ["0357894503019"], "unii": ["4Z63YK6E0E", "743QUY4VD8"], "rxcui": ["2375136", "2375141"], "spl_set_id": ["4bb241af-4299-4373-8762-2d6709515db0"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]", "Glycoside Hydrolases [CS]"], "pharm_class_epc": ["CD38-directed Cytolytic Antibody [EPC]", "Endoglycosidase [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, SINGLE-DOSE in 1 BOX (57894-503-01)  / 15 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "57894-503-01", "marketing_start_date": "20200501"}], "brand_name": "Darzalex Faspro", "product_id": "57894-503_8cd9a8a9-e03e-4557-8b3b-c9d280024acf", "dosage_form": "INJECTION", "pharm_class": ["Antibodies", "Monoclonal [CS]", "CD38-directed Antibody Interactions [MoA]", "CD38-directed Cytolytic Antibody [EPC]", "Endoglycosidase [EPC]", "Glycoside Hydrolases [CS]"], "product_ndc": "57894-503", "generic_name": "daratumumab and hyaluronidase-fihj (human recombinant)", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Darzalex Faspro", "active_ingredients": [{"name": "DARATUMUMAB", "strength": "1800 mg/15mL"}, {"name": "HYALURONIDASE (HUMAN RECOMBINANT)", "strength": "30000 U/15mL"}], "application_number": "BLA761145", "marketing_category": "BLA", "marketing_start_date": "20200501", "listing_expiration_date": "20271231"}