🇺🇸
United States · US · US:50090-7300_89a89899-6387-409a-b941-51a374183b43
terbinafine hydrochloride
Orange BookUNIISPLATC D01AE15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeD01AE15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11500907300030 TABLET in 1 BOTTLE (50090-7300-0)
- ndc11500907300190 TABLET in 1 BOTTLE (50090-7300-1)
Annotations
UNII (FDA Substance ID)
012C11ZU6G
TERBINAFINE HYDROCHLORIDE
RxCUI 235838
Orange Book
A078163
AB
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": "50090-7300_89a89899-6387-409a-b941-51a374183b43",
"productndc": "50090-7300",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078163",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 250MG BASE",
"product_no": "001",
"approval_date": "Jul 2, 2007"
}
],
"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": "ANDA078163",
"marketing_category": "ANDA",
"nonproprietary_name": "terbinafine hydrochloride",
"start_marketing_date": "20220128",
"active_numerator_strength": "250"
}Related drugs
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