Ciprofloxacin Otic

Orange BookUNIISPLATC J01MA02

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

Identification

ManufacturerGenus Lifesciences

CountryUS (United States)

ATC codeJ01MA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6495038114
14 VIAL in 1 CARTON (64950-381-14) / .25 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

5E8K9I0O4U

CIPROFLOXACIN

RxCUI 2551

Orange Book

A217887

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5E8K9I0O4U",
    "rxcui": "2551",
    "inchikey": "MYSWGUAQZAJSOK-UHFFFAOYSA-N",
    "display_name": "CIPROFLOXACIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "AURICULAR (OTIC)",
  "spl_meta": {
    "a05035e1-f941-4f7c-9321-91dd50ab149b": {
      "match": "brand_token",
      "title": "CIPROFLOXACIN TABLET, COATED [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-06-01"
    }
  },
  "productid": "64950-381_3f726b10-ef7b-47d6-96c9-e1a7ee5461d9",
  "productndc": "64950-381",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "217887",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.2% BASE",
        "product_no": "001",
        "approval_date": "Nov 5, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPROFLOXACIN",
  "proprietary_name": "Ciprofloxacin Otic",
  "active_ingred_unit": "mg/.25mL",
  "application_number": "ANDA217887",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciprofloxacin",
  "start_marketing_date": "20241201",
  "active_numerator_strength": ".5"
}

Related drugs

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