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United States · US · US:0187-5400_aa387108-3f36-49af-bbcb-df681d4b9e51
JUBLIA
Orange BookUNIISPLATC D01AC19
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBausch Health US LLC
CountryUS (United States)
ATC codeD01AC19
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1101875400021 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATOR
- ndc1101875400041 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) / 4 mL in 1 BOTTLE, WITH APPLICATOR
- ndc1101875400081 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-08) / 8 mL in 1 BOTTLE, WITH APPLICATOR
Annotations
UNII (FDA Substance ID)
J82SB7FXWB
EFINACONAZOLE
RxCUI 1539753
Orange Book
N203567
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "J82SB7FXWB",
"rxcui": "1539753",
"inchikey": "NFEZZTICAUWDHU-RDTXWAMCSA-N",
"display_name": "EFINACONAZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"922d4d25-c530-11e1-9b21-0800200c9a66": {
"match": "brand_token",
"title": "JUBLIA (EFINACONAZOLE) SOLUTION [BAUSCH HEALTH US LLC]",
"spl_version": "21",
"published_date": "2025-08-18"
}
},
"productid": "0187-5400_aa387108-3f36-49af-bbcb-df681d4b9e51",
"productndc": "0187-5400",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "203567",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "10%",
"product_no": "001",
"approval_date": "Jun 6, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EFINACONAZOLE",
"proprietary_name": "JUBLIA",
"active_ingred_unit": "mg/mL",
"application_number": "NDA203567",
"marketing_category": "NDA",
"nonproprietary_name": "efinaconazole",
"start_marketing_date": "20140606",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code D01AC19.
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