Ciprofloxacin HCl Ophthalmic

Orange BookUNIISPLATC J01MA02

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

Identification

ManufacturerAltaire Pharmaceuticals Inc.

CountryUS (United States)

ATC codeJ01MA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5939021702
2.5 mL in 1 BOTTLE, PLASTIC (59390-217-02)
ndc11
5939021705
5 mL in 1 BOTTLE, PLASTIC (59390-217-05)
ndc11
5939021710
10 mL in 1 BOTTLE, PLASTIC (59390-217-10)

Annotations

UNII (FDA Substance ID)

4BA73M5E37

CIPROFLOXACIN HYDROCHLORIDE

RxCUI 81981

Orange Book

A204613

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": {
    "a05035e1-f941-4f7c-9321-91dd50ab149b": {
      "match": "brand_token",
      "title": "CIPROFLOXACIN TABLET, COATED [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-06-01"
    }
  },
  "productid": "59390-217_f31149b7-60fc-4cef-8270-5eb8ff2b42bb",
  "productndc": "59390-217",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "204613",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "EQ 0.3% BASE",
        "product_no": "001",
        "approval_date": "May 3, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPROFLOXACIN HYDROCHLORIDE",
  "proprietary_name": "Ciprofloxacin HCl Ophthalmic",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA204613",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciprofloxacin Hydrochloride",
  "start_marketing_date": "20180504",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code J01MA02.

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