🇺🇸
United States · US · US:65862-079_8f6e6ae9-4903-4823-b788-de387e8c6fb2
Terbinafine
Orange BookUNIISPLATC D01AE15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeD01AE15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116586207901100 TABLET in 1 BOTTLE (65862-079-01)
- ndc11658620793030 TABLET in 1 BOTTLE (65862-079-30)
- ndc1165862079991000 TABLET in 1 BOTTLE (65862-079-99)
Annotations
UNII (FDA Substance ID)
012C11ZU6G
TERBINAFINE HYDROCHLORIDE
RxCUI 235838
Orange Book
A078297
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": "65862-079_8f6e6ae9-4903-4823-b788-de387e8c6fb2",
"productndc": "65862-079",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078297",
"products": [
{
"rs": true,
"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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078297",
"marketing_category": "ANDA",
"nonproprietary_name": "Terbinafine Hydrochloride",
"start_marketing_date": "20070702",
"active_numerator_strength": "250"
}Related drugs
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