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United States · US · US:50066-080_38f62b9e-4081-44e8-e063-6394a90a1f3a
Silka
Orange BookUNIISPLATC D01AE15
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenomma Lab USA, Inc.
CountryUS (United States)
ATC codeD01AE15
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1150066080021 TUBE in 1 CARTON (50066-080-02) / 30 g in 1 TUBE
- ndc1150066080031 TUBE in 1 CARTON (50066-080-03) / 30 g in 1 TUBE
- ndc1150066080051 TUBE in 1 CARTON (50066-080-05) / 15 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
012C11ZU6G
TERBINAFINE HYDROCHLORIDE
RxCUI 235838
Orange Book
A077511
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": "TOPICAL",
"spl_meta": {
"fb1dc636-837f-491c-97c1-e74288aebc27": {
"match": "brand_token",
"title": "SILKA ANTIFUNGAL (TOLNAFTATE) LIQUID [GENOMMA LAB USA]",
"spl_version": "1",
"published_date": "2025-10-02"
}
},
"productid": "50066-080_38f62b9e-4081-44e8-e063-6394a90a1f3a",
"productndc": "50066-080",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "077511",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1%",
"product_no": "001",
"approval_date": "Jul 2, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "TERBINAFINE HYDROCHLORIDE",
"proprietary_name": "Silka",
"active_ingred_unit": "g/100g",
"application_number": "ANDA077511",
"marketing_category": "ANDA",
"nonproprietary_name": "Terbinafine Hydrochloride",
"start_marketing_date": "20070702",
"active_numerator_strength": "1"
}Related drugs
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