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United States · US · US:0378-9720_3f576b33-fe11-41ec-b6d2-6ed89b58fbcb
Denavir
Orange BookUNIISPLATC J05AB13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ05AB13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103789720551 TUBE in 1 CARTON (0378-9720-55) / 5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
359HUE8FJC
PENCICLOVIR
RxCUI 59839
Orange Book
N020629
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": {
"61229829-55a0-4d6f-a423-4b48a2b4d8e5": {
"match": "brand_token",
"title": "DENAVIR (PENCICLOVIR) CREAM [MYLAN PHARMACEUTICALS INC.]",
"spl_version": "5",
"published_date": "2025-01-30"
}
},
"productid": "0378-9720_3f576b33-fe11-41ec-b6d2-6ed89b58fbcb",
"productndc": "0378-9720",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "020629",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "1%",
"product_no": "001",
"approval_date": "Sep 24, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PENCICLOVIR",
"proprietary_name": "Denavir",
"active_ingred_unit": "mg/g",
"application_number": "NDA020629",
"marketing_category": "NDA",
"nonproprietary_name": "penciclovir",
"start_marketing_date": "20180924",
"active_numerator_strength": "10"
}Related drugs
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- 🇪🇸FENISTIL 1 mg/g GELHaleon Spain S.A.
- 🇪🇸FENISTIL 1 MG/G GELHaleon Hellas Single Member S.A.
- 🇪🇸FENISTIL 1 MG/ML EMULSION CUTANEAGlaxosmithkline Consumer Healthcare Hellas S.A.
- 🇪🇸FENISTIL 1 MG/ML EMULSIÓN CUTÁNEAHaleon Spain S.A.
- GBFenistil Cold Sore 1% creamOmega Pharma Ltd
- 🇪🇸FENISTIL EMULSIONGlaxosmithkline Consumer Healthcare Hellas S.A.
- 🇺🇸PenciclovirTorrent Pharmaceuticals Limited
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