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United States · US · US:24208-535_52207853-4445-f142-e063-6394a90a281c

ZIRGAN

Orange BookUNIISPLATC S01AD09

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeS01AD09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2420853515
    1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) / 1.5 g in 1 TUBE, WITH APPLICATOR
  • ndc11
    2420853535
    1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) / 5 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
P9G3CKZ4P5
GANCICLOVIR
RxCUI 4678
Orange Book
N022211
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "P9G3CKZ4P5",
    "rxcui": "4678",
    "inchikey": "IRSCQMHQWWYFCW-UHFFFAOYSA-N",
    "display_name": "GANCICLOVIR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "ea25e7ac-7a93-4ec8-975b-2cec197e1c27": {
      "match": "brand_token",
      "title": "ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED]",
      "spl_version": "15",
      "published_date": "2026-05-21"
    }
  },
  "productid": "24208-535_52207853-4445-f142-e063-6394a90a281c",
  "productndc": "24208-535",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "022211",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.15%",
        "product_no": "001",
        "approval_date": "Sep 15, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GANCICLOVIR",
  "proprietary_name": "ZIRGAN",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA022211",
  "marketing_category": "NDA",
  "nonproprietary_name": "ganciclovir",
  "start_marketing_date": "20100430",
  "active_numerator_strength": "1.5"
}

Related drugs

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