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United States · US · US:67457-210_e7774227-c6ba-439d-a32f-01b67d010fc5

CIDOFOVIR

Orange BookUNIISPLATC J05AB12

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

Identification

ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeJ05AB12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6745721005
    1 VIAL, GLASS in 1 CARTON (67457-210-05) / 5 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
JIL713Q00N
CIDOFOVIR
RxCUI 83171
Orange Book
A201276
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": "67457-210_e7774227-c6ba-439d-a32f-01b67d010fc5",
  "productndc": "67457-210",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "201276",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 375MG BASE/5ML (EQ 75MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jun 27, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIDOFOVIR",
  "proprietary_name": "CIDOFOVIR",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA201276",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cidofovir Anhydrous",
  "start_marketing_date": "20130603",
  "active_numerator_strength": "75"
}

Related drugs

Other records sharing ATC code J05AB12.

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