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United States · US · US:50090-5810_3b41da76-67b3-4921-ae37-d0be4c8ada4c
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 · 1
- ndc1150090581001 TUBE in 1 CARTON (50090-5810-0) / 30 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
012C11ZU6G
TERBINAFINE HYDROCHLORIDE
RxCUI 235838
Orange Book
A077511
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": "TOPICAL",
"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": "50090-5810_3b41da76-67b3-4921-ae37-d0be4c8ada4c",
"productndc": "50090-5810",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "077511",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1%",
"product_no": "001",
"approval_date": "Jul 2, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "TERBINAFINE HYDROCHLORIDE",
"proprietary_name": "Terbinafine Hydrochloride",
"active_ingred_unit": "g/100g",
"application_number": "ANDA077511",
"marketing_category": "ANDA",
"nonproprietary_name": "Terbinafine Hydrochloride",
"start_marketing_date": "20070702",
"active_numerator_strength": "1"
}Related drugs
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