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United States · US · US:50090-6043_cad2cea9-68bf-4e4e-afc6-60bd21846b6c

CIPRO

Orange BookUNIISPLATC J01MA

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ01MA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009060430
    10 mL in 1 BOTTLE (50090-6043-0)

Annotations

UNII (FDA Substance ID)
4BA73M5E37
CIPROFLOXACIN HYDROCHLORIDE
RxCUI 81981
Orange Book
N020805
AB
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": "AURICULAR (OTIC)",
  "spl_meta": {
    "888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0": {
      "match": "brand_token",
      "title": "CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "32",
      "published_date": "2026-03-04"
    }
  },
  "productid": "50090-6043_cad2cea9-68bf-4e4e-afc6-60bd21846b6c",
  "productndc": "50090-6043",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "020805",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.2% BASE;1%",
        "product_no": "001",
        "approval_date": "Feb 10, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE",
  "proprietary_name": "CIPRO",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA020805",
  "marketing_category": "NDA",
  "nonproprietary_name": "ciprofloxacin hydrochloride and hydrocortisone",
  "start_marketing_date": "19990315",
  "active_numerator_strength": "2; 10"
}

Related drugs

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