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United States · US · US:70437-240_44eb88a3-0ac0-2880-e063-6394a90af02f
Nerlynx
Orange BookUNIISPLATC L01EH02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPuma Biotechnology, Inc.
CountryUS (United States)
ATC codeL01EH02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1170437240181 BOTTLE in 1 BOX (70437-240-18) / 180 TABLET in 1 BOTTLE
- ndc1170437240261 BOTTLE in 1 BOX (70437-240-26) / 126 TABLET in 1 BOTTLE
- ndc1170437240331 BOTTLE in 1 BOX (70437-240-33) / 133 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
9RM7XY23ZS
NERATINIB MALEATE ANHYDROUS
RxCUI 1940642
Orange Book
N208051
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9RM7XY23ZS",
"rxcui": "1940642",
"inchikey": "VXZCUHNJXSIJIM-MEBGWEOYSA-N",
"display_name": "NERATINIB MALEATE ANHYDROUS",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d1e41dcf-e82a-47c2-a0ad-6c6eef621834": {
"match": "brand_token",
"title": "NERLYNX (NERATINIB) TABLET [PUMA BIOTECHNOLOGY, INC.]",
"spl_version": "18",
"published_date": "2025-12-02"
}
},
"productid": "70437-240_44eb88a3-0ac0-2880-e063-6394a90af02f",
"productndc": "70437-240",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208051",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 40MG BASE",
"product_no": "001",
"approval_date": "Jul 17, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NERATINIB MALEATE ANHYDROUS",
"proprietary_name": "Nerlynx",
"active_ingred_unit": "mg/1",
"application_number": "NDA208051",
"marketing_category": "NDA",
"nonproprietary_name": "neratinib",
"start_marketing_date": "20170717",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code L01EH02.
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