Ciprofloxacin

Orange BookUNIISPLATC J01MA02

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

Identification

ManufacturerMethod Pharmaceuticals, LLC

CountryUS (United States)

ATC codeJ01MA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5865767601
100 TABLET, COATED in 1 BOTTLE (58657-676-01)

Annotations

UNII (FDA Substance ID)

4BA73M5E37

CIPROFLOXACIN HYDROCHLORIDE

RxCUI 81981

Orange Book

A208921

ABAB

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": "ORAL",
  "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": "58657-676_41b40647-01ce-1916-e063-6394a90aaadd",
  "productndc": "58657-676",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "208921",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Jun 22, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Jun 22, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPROFLOXACIN HYDROCHLORIDE",
  "proprietary_name": "Ciprofloxacin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208921",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciprofloxacin",
  "start_marketing_date": "20200812",
  "active_numerator_strength": "500"
}

Related drugs

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