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United States · US · US:51672-1362_39620da3-e660-e94f-e063-6294a90afd69
Naftifine Hydrochloride
Orange BookUNIISPLATC D01AE22
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeD01AE22
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1151672136211 TUBE in 1 CARTON (51672-1362-1) / 15 g in 1 TUBE
- ndc1151672136221 TUBE in 1 CARTON (51672-1362-2) / 30 g in 1 TUBE
- ndc1151672136231 TUBE in 1 CARTON (51672-1362-3) / 60 g in 1 TUBE
- ndc1151672136281 TUBE in 1 CARTON (51672-1362-8) / 90 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
25UR9N9041
NAFTIFINE HYDROCHLORIDE
RxCUI 91293
Orange Book
A205975
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "25UR9N9041",
"rxcui": "91293",
"inchikey": "OLUNPKFOFGZHRT-YGCVIUNWSA-N",
"display_name": "NAFTIFINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"92d3ec30-2176-49cd-8a70-668ef65e7663": {
"match": "brand_token",
"title": "NAFTIFINE HYDROCHLORIDE GEL [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "11",
"published_date": "2026-02-16"
}
},
"productid": "51672-1362_39620da3-e660-e94f-e063-6294a90afd69",
"productndc": "51672-1362",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "205975",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "1%",
"product_no": "001",
"approval_date": "Sep 8, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAFTIFINE HYDROCHLORIDE",
"proprietary_name": "Naftifine Hydrochloride",
"active_ingred_unit": "mg/g",
"application_number": "ANDA205975",
"marketing_category": "ANDA",
"nonproprietary_name": "Naftifine Hydrochloride",
"start_marketing_date": "20160908",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code D01AE22.
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