balversa

Generic: erdafitinib

Labeler: janssen products lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name balversa
Generic Name erdafitinib
Labeler janssen products lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

erdafitinib 3 mg/1

Manufacturer
Janssen Products LP

Identifiers & Regulatory

Product NDC 59676-030
Product ID 59676-030_41ec18e6-999d-f298-e063-6294a90aa2dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212018
Listing Expiration 2026-12-31
Marketing Start 2019-04-12

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
fibroblast growth factor receptor inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] cytochrome p450 3a4 inducers [moa] p-glycoprotein inhibitors [moa] organic cation transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59676030
Hyphenated Format 59676-030

Supplemental Identifiers

RxCUI
2123131 2123137 2123139 2123141 2123143 2123145
UNII
890E37NHMV
NUI
N0000175605 N0000194026 N0000182141 N0000185506 N0000185503 N0000187061

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 balversa (source: ndc)
Generic Name erdafitinib (source: ndc)
Application Number NDA212018 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59676-030-56) / 56 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (59676-030-84) / 84 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

59676-030-56 1 BOTTLE in 1 CARTON (59676-030-56) / 56 TABLET, FILM COATED in 1 BOTTLE 59676-030-84 1 BOTTLE in 1 CARTON (59676-030-84) / 84 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

erdafitinib (3 mg/1)

Linked Drug Pages (1)

BALVERSA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41ec18e6-999d-f298-e063-6294a90aa2dc", "openfda": {"nui": ["N0000175605", "N0000194026", "N0000182141", "N0000185506", "N0000185503", "N0000187061"], "unii": ["890E37NHMV"], "rxcui": ["2123131", "2123137", "2123139", "2123141", "2123143", "2123145"], "spl_set_id": ["2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Fibroblast Growth Factor Receptor Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Janssen Products LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59676-030-56)  / 56 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "59676-030-56", "marketing_start_date": "20190412"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (59676-030-84)  / 84 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "59676-030-84", "marketing_start_date": "20190412"}], "brand_name": "BALVERSA", "product_id": "59676-030_41ec18e6-999d-f298-e063-6294a90aa2dc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Fibroblast Growth Factor Receptor Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Organic Cation Transporter 2 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "59676-030", "generic_name": "Erdafitinib", "labeler_name": "Janssen Products LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BALVERSA", "active_ingredients": [{"name": "ERDAFITINIB", "strength": "3 mg/1"}], "application_number": "NDA212018", "marketing_category": "NDA", "marketing_start_date": "20190412", "listing_expiration_date": "20261231"}