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United States · US · US:0597-0143_5c860918-0d7e-4aaf-b103-85f66e9dcdbe
Ofev
Orange BookUNIISPLATC L01EX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01EX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105970143601 BOTTLE in 1 CARTON (0597-0143-60) / 60 CAPSULE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
42F62RTZ4G
NINTEDANIB ESYLATE
RxCUI 1592736
Orange Book
N205832
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "42F62RTZ4G",
"rxcui": "1592736",
"inchikey": "MMMVNAGRWOJNMW-FJBFXRHMSA-N",
"display_name": "NINTEDANIB ESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"da1c9f37-779e-4682-816f-93d0faa4cfc9": {
"match": "brand_token",
"title": "OFEV (NINTEDANIB) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
"spl_version": "21",
"published_date": "2025-11-21"
}
},
"productid": "0597-0143_5c860918-0d7e-4aaf-b103-85f66e9dcdbe",
"productndc": "0597-0143",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "205832",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Oct 15, 2014"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Oct 15, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NINTEDANIB ESYLATE",
"proprietary_name": "Ofev",
"active_ingred_unit": "mg/1",
"application_number": "NDA205832",
"marketing_category": "NDA",
"nonproprietary_name": "nintedanib",
"start_marketing_date": "20141015",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01EX09.
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