Cipro

Orange BookSPL

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

Identification

ManufacturerBayer HealthCare Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5041977701
1 KIT in 1 KIT (50419-777-01) * 100 mL in 1 BOTTLE, GLASS * 100 mL in 1 BOTTLE, PLASTIC

Annotations

Orange Book

N020780

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "50419-777_1b112839-6cf0-466a-9188-86fc5b1549f9",
  "productndc": "50419-777",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "020780",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG/5ML",
        "product_no": "001",
        "approval_date": "Sep 26, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "500MG/5ML",
        "product_no": "002",
        "approval_date": "Sep 26, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Cipro",
  "active_ingred_unit": null,
  "application_number": "NDA020780",
  "marketing_category": "NDA",
  "nonproprietary_name": "ciprofloxacin",
  "start_marketing_date": "19970926",
  "active_numerator_strength": null
}

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