🇺🇸
United States · US · US:54766-772_43150f38-df38-5e12-e063-6294a90a1128
Naftin
Orange BookUNIISPLATC D01AE22
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSebela Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD01AE22
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1154766772451 TUBE in 1 CARTON (54766-772-45) / 45 g in 1 TUBE
- ndc1154766772601 TUBE in 1 CARTON (54766-772-60) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
25UR9N9041
NAFTIFINE HYDROCHLORIDE
RxCUI 91293
Orange Book
N204286
AB
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": {
"6645994a-ecb3-277b-e053-2a91aa0a81e5": {
"match": "brand_token",
"title": "NAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [SEBELA PHARMACEUTICALS INC.]",
"spl_version": "7",
"published_date": "2025-11-17"
}
},
"productid": "54766-772_43150f38-df38-5e12-e063-6294a90a1128",
"productndc": "54766-772",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "204286",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "2%",
"product_no": "001",
"approval_date": "Jun 27, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAFTIFINE HYDROCHLORIDE",
"proprietary_name": "Naftin",
"active_ingred_unit": "g/100g",
"application_number": "NDA204286",
"marketing_category": "NDA",
"nonproprietary_name": "Naftifine Hydrochloride",
"start_marketing_date": "20180301",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code D01AE22.
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- 🇺🇸Naftifine HydrochlorideSun Pharmaceutical Industries, Inc.
- 🇺🇸Naftifine HydrochlorideSun Pharmaceutical Industries, Inc.
- 🇺🇸Naftifine HydrochlorideSun Pharmaceutical Industries, Inc.
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