Ciprofloxacin

Orange BookUNIISPLATC J01MA02

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

Identification

ManufacturerSagent Pharmaceuticals

CountryUS (United States)

ATC codeJ01MA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
2502111482
24 POUCH in 1 CARTON (25021-114-82) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
ndc11
2502111487
24 POUCH in 1 CARTON (25021-114-87) / 1 BAG in 1 POUCH / 200 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

5E8K9I0O4U

CIPROFLOXACIN

RxCUI 2551

Orange Book

A078252

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5E8K9I0O4U",
    "rxcui": "2551",
    "inchikey": "MYSWGUAQZAJSOK-UHFFFAOYSA-N",
    "display_name": "CIPROFLOXACIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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": "25021-114_c30953aa-a1e5-45b5-97a5-6bb9d0b0bd6f",
  "productndc": "25021-114",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "078252",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/100ML",
        "product_no": "001",
        "approval_date": "Mar 18, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "400MG/200ML",
        "product_no": "002",
        "approval_date": "Mar 18, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPROFLOXACIN",
  "proprietary_name": "Ciprofloxacin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078252",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ciprofloxacin",
  "start_marketing_date": "20080324",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code J01MA02.

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