Package 57894-650-02
Brand: tremfya
Generic: guselkumabPackage Facts
Identity
Package NDC
57894-650-02
Digits Only
5789465002
Product NDC
57894-650
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (57894-650-02) / 20 mL in 1 VIAL, SINGLE-DOSE (57894-650-01)
Marketing
Marketing Status
Brand
tremfya
Generic
guselkumab
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "ebe07a22-1b8b-4403-99dc-e7f34308d5d0", "openfda": {"nui": ["N0000192799", "N0000192798"], "unii": ["089658A12D"], "rxcui": ["1928686", "1928689", "2118739", "2118741", "2693088", "2693092", "2693094", "2693095", "2693096", "2693097", "2711637", "2711638"], "spl_set_id": ["1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56"], "pharm_class_epc": ["Interleukin-23 Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-23 Antagonists [MoA]"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (57894-650-02) / 20 mL in 1 VIAL, SINGLE-DOSE (57894-650-01)", "package_ndc": "57894-650-02", "marketing_start_date": "20240911"}], "brand_name": "TREMFYA", "product_id": "57894-650_ebe07a22-1b8b-4403-99dc-e7f34308d5d0", "dosage_form": "INJECTION", "pharm_class": ["Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "57894-650", "generic_name": "Guselkumab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TREMFYA", "active_ingredients": [{"name": "GUSELKUMAB", "strength": "200 mg/20mL"}], "application_number": "BLA761061", "marketing_category": "BLA", "marketing_start_date": "20240911", "listing_expiration_date": "20271231"}