ciprofloxacin

Orange BookUNIISPLATC J01MA02

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

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC codeJ01MA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0904724361
100 BLISTER PACK in 1 CARTON (0904-7243-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
0904724395
20 TABLET, FILM COATED in 1 BOTTLE (0904-7243-95)

Annotations

UNII (FDA Substance ID)

4BA73M5E37

CIPROFLOXACIN HYDROCHLORIDE

RxCUI 81981

Orange Book

A076639

ABABAB

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": "0904-7243_ec371e89-c5cc-4142-a3b6-38297f9b6dc3",
  "productndc": "0904-7243",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076639",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Sep 10, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Sep 10, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 750MG BASE",
        "product_no": "003",
        "approval_date": "Sep 10, 2004"
      }
    ],
    "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": "ANDA076639",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ciprofloxacin",
  "start_marketing_date": "20220823",
  "active_numerator_strength": "500"
}

Related drugs

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