🇺🇸
United States · US · US:51991-526_1603cd34-5cf4-4130-966f-c156d9237346
Terbinafine Hydrochloride
Orange BookUNIISPLATC D01AE15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBreckenridge Pharmaceutical, Inc.
CountryUS (United States)
ATC codeD01AE15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115199152601100 TABLET in 1 BOTTLE (51991-526-01)
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": "51991-526_1603cd34-5cf4-4130-966f-c156d9237346",
"productndc": "51991-526",
"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": "20101227",
"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.