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United States · US · US:71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed
Terbinafine Hydrochloride
Orange BookUNIISPLATC D01AE15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeD01AE15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc11712051271414 TABLET in 1 BOTTLE (71205-127-14)
- ndc11712051271515 TABLET in 1 BOTTLE (71205-127-15)
- ndc11712051273030 TABLET in 1 BOTTLE (71205-127-30)
- ndc11712051273535 TABLET in 1 BOTTLE (71205-127-35)
- ndc11712051274242 TABLET in 1 BOTTLE (71205-127-42)
- ndc11712051274545 TABLET in 1 BOTTLE (71205-127-45)
- ndc11712051276060 TABLET in 1 BOTTLE (71205-127-60)
- ndc11712051279090 TABLET in 1 BOTTLE (71205-127-90)
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": "71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed",
"productndc": "71205-127",
"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
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