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United States · US · US:69097-686_01ca8568-cd52-42e0-87b8-2eea35a77364
TAVABOROLE
Orange BookUNIISPLATC D01AE24
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeD01AE24
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169097686371 BOTTLE, WITH APPLICATOR in 1 CARTON (69097-686-37) / 10 mL in 1 BOTTLE, WITH APPLICATOR
Annotations
UNII (FDA Substance ID)
K124A4EUQ3
TAVABOROLE
RxCUI 1543173
Orange Book
A212224
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": "69097-686_01ca8568-cd52-42e0-87b8-2eea35a77364",
"productndc": "69097-686",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "212224",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5%",
"product_no": "001",
"approval_date": "Feb 9, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TAVABOROLE",
"proprietary_name": "TAVABOROLE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212224",
"marketing_category": "ANDA",
"nonproprietary_name": "TAVABOROLE",
"start_marketing_date": "20210218",
"active_numerator_strength": "43.5"
}Related drugs
Other records sharing ATC code D01AE24.
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