🇺🇸
United States · US · US:55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057
Terbinafine Hydrochloride
Orange BookUNIISPLATC D01AE15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddys Laboratories Limited
CountryUS (United States)
ATC codeD01AE15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc115511125001100 TABLET in 1 BOTTLE (55111-250-01)
- ndc115511125005500 TABLET in 1 BOTTLE (55111-250-05)
- ndc11551112503030 TABLET in 1 BOTTLE (55111-250-30)
- ndc11551112507910 BLISTER PACK in 1 CARTON (55111-250-79) / 10 TABLET in 1 BLISTER PACK (55111-250-78)
- ndc11551112509090 TABLET in 1 BOTTLE (55111-250-90)
Annotations
UNII (FDA Substance ID)
012C11ZU6G
TERBINAFINE HYDROCHLORIDE
RxCUI 235838
Orange Book
A076390
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": "55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057",
"productndc": "55111-250",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076390",
"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": "ANDA076390",
"marketing_category": "ANDA",
"nonproprietary_name": "Terbinafine Hydrochloride",
"start_marketing_date": "20070702",
"active_numerator_strength": "250"
}Related drugs
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