Ciprofloxacin

Orange BookUNIISPLATC J01MA02

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ01MA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7278951906
6 TABLET in 1 BOTTLE, PLASTIC (72789-519-06)
ndc11
7278951910
10 TABLET in 1 BOTTLE, PLASTIC (72789-519-10)
ndc11
7278951912
12 TABLET in 1 BOTTLE, PLASTIC (72789-519-12)
ndc11
7278951914
14 TABLET in 1 BOTTLE, PLASTIC (72789-519-14)
ndc11
7278951920
20 TABLET in 1 BOTTLE, PLASTIC (72789-519-20)

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": "72789-519_3f92e4b4-bd66-8f5d-e063-6394a90aa46d",
  "productndc": "72789-519",
  "dosage_form": "TABLET",
  "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": "Ciprofolxacin",
  "start_marketing_date": "20231001",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code J01MA02.

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