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United States · US · US:60505-4818_5fbe2775-85bd-4ab4-1552-8bff1f050dc5
Nintedanib
Orange BookUNIISPLATC L01EX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeL01EX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160505481861 BOTTLE in 1 CARTON (60505-4818-6) / 60 CAPSULE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
42F62RTZ4G
NINTEDANIB ESYLATE
RxCUI 1592736
Orange Book
A219227
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": {
"60d8104e-cb6c-4f4f-8159-95ed57346ffa": {
"match": "brand_token",
"title": "NINTEDANIB CAPSULES, 100 MG AND 150 MG (NINTEDANIB) CAPSULE [EXELAN PHARMACEUTICALS INC.]",
"spl_version": "1",
"published_date": "2026-05-11"
}
},
"productid": "60505-4818_5fbe2775-85bd-4ab4-1552-8bff1f050dc5",
"productndc": "60505-4818",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "219227",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Apr 2, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Apr 2, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NINTEDANIB ESYLATE",
"proprietary_name": "Nintedanib",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219227",
"marketing_category": "ANDA",
"nonproprietary_name": "Nintedanib",
"start_marketing_date": "20260402",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01EX09.
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