ciprofloxacin

Orange BookSPL

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

Identification

ManufacturerChartwell RX, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6213539342
1 KIT in 1 KIT (62135-393-42) * 100 mL in 1 BOTTLE * 100 mL in 1 BOTTLE

Annotations

Orange Book

A200563

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "62135-393_459c475d-c9e2-ffa6-e063-6394a90add66",
  "productndc": "62135-393",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "200563",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG/5ML",
        "product_no": "001",
        "approval_date": "Mar 5, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG/5ML",
        "product_no": "002",
        "approval_date": "Mar 5, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ciprofloxacin",
  "active_ingred_unit": null,
  "application_number": "ANDA200563",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ciprofloxacin",
  "start_marketing_date": "20140305",
  "active_numerator_strength": null
}

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