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United States · US · US:72162-1126_fdda6ce3-b610-4510-95fc-0df24f9e5903

CICLOPIROX

Orange BookUNIISPLATC D01AE14

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD01AE14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7216211261
    1 TUBE in 1 CARTON (72162-1126-1) / 100 g in 1 TUBE
  • ndc11
    7216211262
    1 TUBE in 1 CARTON (72162-1126-2) / 45 g in 1 TUBE
  • ndc11
    7216211263
    1 TUBE in 1 CARTON (72162-1126-3) / 30 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
19W019ZDRJ
CICLOPIROX
RxCUI 21090
Orange Book
A078266
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "19W019ZDRJ",
    "rxcui": "21090",
    "inchikey": "SCKYRAXSEDYPSA-UHFFFAOYSA-N",
    "display_name": "CICLOPIROX",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "1a74ed86-997a-4b86-b54a-b2b2c94e8abb": {
      "match": "brand_token",
      "title": "CICLOPIROX OLAMINE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]",
      "spl_version": "14",
      "published_date": "2026-04-17"
    }
  },
  "productid": "72162-1126_fdda6ce3-b610-4510-95fc-0df24f9e5903",
  "productndc": "72162-1126",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "078266",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.77%",
        "product_no": "001",
        "approval_date": "Jan 7, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CICLOPIROX",
  "proprietary_name": "CICLOPIROX",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA078266",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CICLOPIROX",
  "start_marketing_date": "20090107",
  "active_numerator_strength": "7.7"
}

Related drugs

Other records sharing ATC code D01AE14.

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