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United States · US · US:42023-173_f04cdda8-4829-4fa1-8cf2-503479c89b1e

Ganciclovir

Orange BookUNIISPLATC S01AD09

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

Identification

ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeS01AD09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4202317325
    25 VIAL, SINGLE-DOSE in 1 CARTON (42023-173-25) / 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01)

Annotations

UNII (FDA Substance ID)
02L083W284
GANCICLOVIR SODIUM
RxCUI 82131
Orange Book
A204950
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "02L083W284",
    "rxcui": "82131",
    "inchikey": "JJICLMJFIKGAAU-UHFFFAOYSA-M",
    "display_name": "GANCICLOVIR SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "35addab5-09db-4f8a-9c69-6fbce33ecc37": {
      "match": "brand_token",
      "title": "GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "6",
      "published_date": "2026-02-12"
    }
  },
  "productid": "42023-173_f04cdda8-4829-4fa1-8cf2-503479c89b1e",
  "productndc": "42023-173",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "204950",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 6, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GANCICLOVIR SODIUM",
  "proprietary_name": "Ganciclovir",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA204950",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ganciclovir",
  "start_marketing_date": "20161206",
  "active_numerator_strength": "500"
}

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