🇺🇸
United States · US · US:43353-893_280bbc43-14a1-47e0-a702-8cd8117c2978
Terbinafine Hydrochloride
Orange BookUNIISPLATC D01AE15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeD01AE15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143353893166000 TABLET in 1 BOTTLE (43353-893-16)
Annotations
UNII (FDA Substance ID)
012C11ZU6G
TERBINAFINE HYDROCHLORIDE
RxCUI 235838
Orange Book
A077714
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "012C11ZU6G",
"rxcui": "235838",
"inchikey": "BWMISRWJRUSYEX-SZKNIZGXSA-N",
"display_name": "TERBINAFINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"50750500-6cb0-62dc-e063-6294a90a15bc": {
"match": "brand_token",
"title": "TERBINAFINE HYDROCHLORIDE (TERBINAFINE TABLETS 250 MG) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "1",
"published_date": "2026-04-29"
}
},
"productid": "43353-893_280bbc43-14a1-47e0-a702-8cd8117c2978",
"productndc": "43353-893",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077714",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Jun 4, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TERBINAFINE HYDROCHLORIDE",
"proprietary_name": "Terbinafine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077714",
"marketing_category": "ANDA",
"nonproprietary_name": "Terbinafine Hydrochloride",
"start_marketing_date": "20120822",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code D01AE15.
- 🇺🇸AntifungalMeijer Distribution Inc
- NLAntischimmelcrème HTP Terbinafine HCl 10 mg/g, crèmeHealthypharm B.V.
- GBAthlete Foot 1% creamRatiopharm UK Ltd
- 🇺🇸Athlete Foot CreamBeautivity LLC
- 🇺🇸Athletes FootRite Aid Corporation
- 🇺🇸Athletes FootH E B
- 🇺🇸Athletes FootPublix Super Markets Inc.
- NLBinanidda 1% creme, creme 10 mg/gratiopharm GmbH
Access this data programmatically
Query Terbinafine Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.