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United States · US · US:51862-690_12ed0433-3ec5-f721-e063-6294a90adc2b
tavaborole
Orange BookUNIISPLATC D01AE24
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMayne Pharma Commercial LLC
CountryUS (United States)
ATC codeD01AE24
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
K124A4EUQ3
TAVABOROLE
RxCUI 1543173
Orange Book
A211297
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "K124A4EUQ3",
"rxcui": "1543173",
"inchikey": "LFQDNHWZDQTITF-UHFFFAOYSA-N",
"display_name": "TAVABOROLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"37004451-0345-4e00-96be-f05db600fb9f": {
"match": "brand_token",
"title": "TAVABOROLE SOLUTION [CIPLA USA INC.]",
"spl_version": "3",
"published_date": "2025-12-22"
}
},
"productid": "51862-690_12ed0433-3ec5-f721-e063-6294a90adc2b",
"productndc": "51862-690",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "211297",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "5%",
"product_no": "001",
"approval_date": "Oct 13, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TAVABOROLE",
"proprietary_name": "tavaborole",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA211297",
"marketing_category": "ANDA",
"nonproprietary_name": "tavaborole",
"start_marketing_date": "20210201",
"active_numerator_strength": "43.5"
}Related drugs
Other records sharing ATC code D01AE24.
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