CILOXAN

Orange BookUNIISPLATC J01MA02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSandoz Inc

CountryUS (United States)

ATC codeJ01MA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6675807138
3.5 g in 1 TUBE (66758-071-38)

Annotations

UNII (FDA Substance ID)

4BA73M5E37

CIPROFLOXACIN HYDROCHLORIDE

RxCUI 81981

Orange Book

N020369

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4BA73M5E37",
    "rxcui": "81981",
    "inchikey": "ARPUHYJMCVWYCZ-UHFFFAOYSA-N",
    "display_name": "CIPROFLOXACIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "09ca5374-2a16-4a95-91b3-70591d78254e": {
      "match": "brand_token",
      "title": "CILOXAN (CIPROFLOXACIN HYDROCHLORIDE) OINTMENT [SANDOZ INC]",
      "spl_version": "2",
      "published_date": "2025-04-14"
    }
  },
  "productid": "66758-071_930a2e4b-dcac-4a27-a073-fd21622c1666",
  "productndc": "66758-071",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "020369",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.3% BASE",
        "product_no": "001",
        "approval_date": "Mar 30, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPROFLOXACIN HYDROCHLORIDE",
  "proprietary_name": "CILOXAN",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA020369",
  "marketing_category": "NDA",
  "nonproprietary_name": "ciprofloxacin hydrochloride",
  "start_marketing_date": "19980602",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code J01MA02.

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