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United States · US · US:71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818
Terbinafine
Orange BookUNIISPLATC D01AE15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD01AE15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 9
- ndc11713351124130 TABLET in 1 BOTTLE (71335-1124-1)
- ndc11713351124260 TABLET in 1 BOTTLE (71335-1124-2)
- ndc11713351124390 TABLET in 1 BOTTLE (71335-1124-3)
- ndc117133511244100 TABLET in 1 BOTTLE (71335-1124-4)
- ndc1171335112457 TABLET in 1 BOTTLE (71335-1124-5)
- ndc11713351124640 TABLET in 1 BOTTLE (71335-1124-6)
- ndc11713351124745 TABLET in 1 BOTTLE (71335-1124-7)
- ndc11713351124814 TABLET in 1 BOTTLE (71335-1124-8)
- ndc11713351124928 TABLET in 1 BOTTLE (71335-1124-9)
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": "71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818",
"productndc": "71335-1124",
"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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