Ciprofloxacin Hydrochloride

Orange BookUNIISPLATC J01MA02

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeJ01MA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6807133513
10 mL in 1 BOX (68071-3351-3)

Annotations

UNII (FDA Substance ID)

4BA73M5E37

CIPROFLOXACIN HYDROCHLORIDE

RxCUI 81981

Orange Book

N019992

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": "68071-3351_1ce8f03a-6915-908c-e063-6394a90a270c",
  "productndc": "68071-3351",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "019992",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "EQ 0.3% BASE",
        "product_no": "001",
        "approval_date": "Dec 31, 1990"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPROFLOXACIN HYDROCHLORIDE",
  "proprietary_name": "Ciprofloxacin Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019992",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Ciprofloxacin Hydrochloride",
  "start_marketing_date": "20040507",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code J01MA02.

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