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United States · US · US:13668-661_05e9763e-c5f9-4be9-b822-8242a44e76ed
Penciclovir
Orange BookUNIISPLATC J05AB13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ05AB13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1113668661101 TUBE in 1 CARTON (13668-661-10) / 5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
359HUE8FJC
PENCICLOVIR
RxCUI 59839
Orange Book
A216981
BX
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "359HUE8FJC",
"rxcui": "59839",
"inchikey": "JNTOCHDNEULJHD-UHFFFAOYSA-N",
"display_name": "PENCICLOVIR",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"dfbd90ed-4135-486a-807b-27c668154b2e": {
"match": "brand_token",
"title": "PENCICLOVIR CREAM [TORRENT PHARMACEUTICALS LIMITED]",
"spl_version": "7",
"published_date": "2026-05-04"
}
},
"productid": "13668-661_05e9763e-c5f9-4be9-b822-8242a44e76ed",
"productndc": "13668-661",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "216981",
"products": [
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "1%",
"product_no": "001",
"approval_date": "Aug 7, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PENCICLOVIR",
"proprietary_name": "Penciclovir",
"active_ingred_unit": "mg/g",
"application_number": "ANDA216981",
"marketing_category": "ANDA",
"nonproprietary_name": "penciclovir",
"start_marketing_date": "20230807",
"active_numerator_strength": "10"
}Related drugs
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