tremfya

Generic: guselkumab

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

Drug Facts

Product Profile

Brand Name tremfya
Generic Name guselkumab
Labeler janssen biotech, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

guselkumab 100 mg/mL

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-640
Product ID 57894-640_ebe07a22-1b8b-4403-99dc-e7f34308d5d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761061
Listing Expiration 2027-12-31
Marketing Start 2017-07-13

Pharmacologic Class

Established (EPC)
interleukin-23 antagonist [epc]
Mechanism of Action
interleukin-23 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894640
Hyphenated Format 57894-640

Supplemental Identifiers

RxCUI
1928686 1928689 2118739 2118741 2693088 2693092 2693094 2693095 2693096 2693097 2711637 2711638
UNII
089658A12D
NUI
N0000192799 N0000192798

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 tremfya (source: ndc)
Generic Name guselkumab (source: ndc)
Application Number BLA761061 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (57894-640-01) / 1 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (57894-640-04) / 1 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (57894-640-06) / 1 mL in 1 SYRINGE (57894-640-03)
  • 1 SYRINGE in 1 CARTON (57894-640-11) / 1 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (57894-640-99) / 1 mL in 1 SYRINGE
source: ndc

Packages (5)

57894-640-01 1 SYRINGE in 1 CARTON (57894-640-01) / 1 mL in 1 SYRINGE 57894-640-04 1 SYRINGE in 1 CARTON (57894-640-04) / 1 mL in 1 SYRINGE 57894-640-06 1 SYRINGE in 1 CARTON (57894-640-06) / 1 mL in 1 SYRINGE (57894-640-03) 57894-640-11 1 SYRINGE in 1 CARTON (57894-640-11) / 1 mL in 1 SYRINGE 57894-640-99 1 SYRINGE in 1 CARTON (57894-640-99) / 1 mL in 1 SYRINGE

Ingredients (1)

guselkumab (100 mg/mL)

Linked Drug Pages (1)

TREMFYA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "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 SYRINGE in 1 CARTON (57894-640-01)  / 1 mL in 1 SYRINGE", "package_ndc": "57894-640-01", "marketing_start_date": "20170713"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (57894-640-04)  / 1 mL in 1 SYRINGE", "package_ndc": "57894-640-04", "marketing_start_date": "20170713"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (57894-640-06)  / 1 mL in 1 SYRINGE (57894-640-03)", "package_ndc": "57894-640-06", "marketing_start_date": "20250325"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (57894-640-11)  / 1 mL in 1 SYRINGE", "package_ndc": "57894-640-11", "marketing_start_date": "20190128"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (57894-640-99)  / 1 mL in 1 SYRINGE", "package_ndc": "57894-640-99", "marketing_start_date": "20190128"}], "brand_name": "TREMFYA", "product_id": "57894-640_ebe07a22-1b8b-4403-99dc-e7f34308d5d0", "dosage_form": "INJECTION", "pharm_class": ["Interleukin-23 Antagonist [EPC]", "Interleukin-23 Antagonists [MoA]"], "product_ndc": "57894-640", "generic_name": "Guselkumab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TREMFYA", "active_ingredients": [{"name": "GUSELKUMAB", "strength": "100 mg/mL"}], "application_number": "BLA761061", "marketing_category": "BLA", "marketing_start_date": "20170713", "listing_expiration_date": "20271231"}