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United States · US · US:81942-125_1f574fcb-3810-2e5c-e063-6394a90aafd3
XDEMVY
Orange BookUNIISPLATC S01AX25
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTarsus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeS01AX25
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1181942125011 BOTTLE, DROPPER in 1 CARTON (81942-125-01) / 10 mL in 1 BOTTLE, DROPPER
- ndc1181942125991 BOTTLE, DROPPER in 1 CARTON (81942-125-99) / 1.5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
HEH4938D7K
LOTILANER
RxCUI 1998841
Orange Book
N217603
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "HEH4938D7K",
"rxcui": "1998841",
"inchikey": "HDKWFBCPLKNOCK-SFHVURJKSA-N",
"display_name": "LOTILANER",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"ccd9e37c-654e-4e84-8c85-6523457df979": {
"match": "brand_token",
"title": "XDEMVY (LOTILANER OPHTHALMIC SOLUTION) SOLUTION/ DROPS [TARSUS PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2024-08-12"
}
},
"productid": "81942-125_1f574fcb-3810-2e5c-e063-6394a90aafd3",
"productndc": "81942-125",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "217603",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.25%",
"product_no": "001",
"approval_date": "Jul 24, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOTILANER",
"proprietary_name": "XDEMVY",
"active_ingred_unit": "mg/mL",
"application_number": "NDA217603",
"marketing_category": "NDA",
"nonproprietary_name": "Lotilaner ophthalmic solution",
"start_marketing_date": "20230814",
"active_numerator_strength": "2.5"
}Access this data programmatically
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