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United States · US · US:59676-030_41ec18e6-999d-f298-e063-6294a90aa2dc
BALVERSA
Orange BookUNIISPLATC L01EN01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Products LP
CountryUS (United States)
ATC codeL01EN01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1159676030561 BOTTLE in 1 CARTON (59676-030-56) / 56 TABLET, FILM COATED in 1 BOTTLE
- ndc1159676030841 BOTTLE in 1 CARTON (59676-030-84) / 84 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
890E37NHMV
ERDAFITINIB
RxCUI 2123125
Orange Book
N212018
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "890E37NHMV",
"rxcui": "2123125",
"inchikey": "OLAHOMJCDNXHFI-UHFFFAOYSA-N",
"display_name": "ERDAFITINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee": {
"match": "brand_token",
"title": "BALVERSA (ERDAFITINIB) TABLET, FILM COATED [JANSSEN PRODUCTS LP]",
"spl_version": "14",
"published_date": "2025-11-17"
}
},
"productid": "59676-030_41ec18e6-999d-f298-e063-6294a90aa2dc",
"productndc": "59676-030",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212018",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "3MG",
"product_no": "001",
"approval_date": "Apr 12, 2019"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "4MG",
"product_no": "002",
"approval_date": "Apr 12, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Apr 12, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ERDAFITINIB",
"proprietary_name": "BALVERSA",
"active_ingred_unit": "mg/1",
"application_number": "NDA212018",
"marketing_category": "NDA",
"nonproprietary_name": "Erdafitinib",
"start_marketing_date": "20190412",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code L01EN01.
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