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United States · US · US:23155-216_963405a6-8cd9-4d70-9de9-2afc6eab1488

CIDOFOVIR DIHYDRATE

Orange BookUNIISPLATC J05AB12

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ05AB12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2315521631
    5 mL in 1 VIAL, GLASS (23155-216-31)

Annotations

UNII (FDA Substance ID)
JIL713Q00N
CIDOFOVIR
RxCUI 83171
Orange Book
A202501
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "JIL713Q00N",
    "rxcui": "83171",
    "inchikey": "FPKARFMSZDBYQF-ILKKLZGPSA-N",
    "display_name": "CIDOFOVIR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "00747bd8-ac58-43ff-be46-7317c822cd24": {
      "match": "brand_token",
      "title": "CIDOFOVIR DIHYDRATE POWDER [AX PHARMACEUTICAL CORP]",
      "spl_version": "6",
      "published_date": "2025-04-09"
    }
  },
  "productid": "23155-216_963405a6-8cd9-4d70-9de9-2afc6eab1488",
  "productndc": "23155-216",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "202501",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 375MG BASE/5ML (EQ 75MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jul 26, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIDOFOVIR",
  "proprietary_name": "CIDOFOVIR DIHYDRATE",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA202501",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CIDOFOVIR DIHYDRATE",
  "start_marketing_date": "20120806",
  "active_numerator_strength": "375"
}

Related drugs

Other records sharing ATC code J05AB12.

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