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United States · US · US:70518-4421_46904a73-bc1d-58d2-e063-6294a90afd89
Terbinafine
Orange BookUNIISPLATC D01AE15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeD01AE15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11705184421090 TABLET in 1 BOTTLE, PLASTIC (70518-4421-0)
- ndc11705184421145 TABLET in 1 BOTTLE, PLASTIC (70518-4421-1)
- ndc11705184421230 TABLET in 1 BLISTER PACK (70518-4421-2)
- ndc11705184421330 TABLET in 1 BOTTLE, PLASTIC (70518-4421-3)
Annotations
UNII (FDA Substance ID)
012C11ZU6G
TERBINAFINE HYDROCHLORIDE
RxCUI 235838
Orange Book
A077533
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": "70518-4421_46904a73-bc1d-58d2-e063-6294a90afd89",
"productndc": "70518-4421",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077533",
"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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077533",
"marketing_category": "ANDA",
"nonproprietary_name": "Terbinafine",
"start_marketing_date": "20250804",
"active_numerator_strength": "250"
}Related drugs
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