Ciprofloxacin Hydrochloride

Orange BookUNIISPLATC J01MA02

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeJ01MA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
8280426007
7 TABLET, FILM COATED in 1 BOTTLE (82804-260-07)
ndc11
8280426010
10 TABLET, FILM COATED in 1 BOTTLE (82804-260-10)
ndc11
8280426014
14 TABLET, FILM COATED in 1 BOTTLE (82804-260-14)
ndc11
8280426020
20 TABLET, FILM COATED in 1 BOTTLE (82804-260-20)

Annotations

UNII (FDA Substance ID)

4BA73M5E37

CIPROFLOXACIN HYDROCHLORIDE

RxCUI 81981

Orange Book

A076593

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": "82804-260_37eb319b-93c5-4bc5-a580-13d0d3ab3cd7",
  "productndc": "82804-260",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076593",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "002",
        "approval_date": "Jun 9, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "003",
        "approval_date": "Jun 9, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 750MG BASE",
        "product_no": "004",
        "approval_date": "Jun 9, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPROFLOXACIN HYDROCHLORIDE",
  "proprietary_name": "Ciprofloxacin Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076593",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciprofloxacin Hydrochloride",
  "start_marketing_date": "20240523",
  "active_numerator_strength": "500"
}

Related drugs

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