🇺🇸
United States · US · US:45802-440_aa3c82bd-5e27-4b4d-af88-6b80e5779f2c
PENCICLOVIR
Orange BookUNIISPLATC J05AB13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeJ05AB13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1145802440751 TUBE in 1 CARTON (45802-440-75) / 5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
359HUE8FJC
PENCICLOVIR
RxCUI 59839
Orange Book
A212368
AB
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": "45802-440_aa3c82bd-5e27-4b4d-af88-6b80e5779f2c",
"productndc": "45802-440",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "212368",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1%",
"product_no": "001",
"approval_date": "Sep 27, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PENCICLOVIR",
"proprietary_name": "PENCICLOVIR",
"active_ingred_unit": "mg/g",
"application_number": "ANDA212368",
"marketing_category": "ANDA",
"nonproprietary_name": "penciclovir",
"start_marketing_date": "20241107",
"active_numerator_strength": "10"
}Related drugs
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