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United States · US · US:0378-0896_6c831562-21df-42b9-92af-b5da4fcf484f

Penciclovir

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

  • ndc11
    0378089655
    1 TUBE in 1 CARTON (0378-0896-55) / 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": {
    "dfbd90ed-4135-486a-807b-27c668154b2e": {
      "match": "brand_token",
      "title": "PENCICLOVIR CREAM [TORRENT PHARMACEUTICALS LIMITED]",
      "spl_version": "7",
      "published_date": "2026-05-04"
    }
  },
  "productid": "0378-0896_6c831562-21df-42b9-92af-b5da4fcf484f",
  "productndc": "0378-0896",
  "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": "Penciclovir",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA020629",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "penciclovir",
  "start_marketing_date": "20221116",
  "active_numerator_strength": "10"
}

Related drugs

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