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United States · US · US:50419-758_1b112839-6cf0-466a-9188-86fc5b1549f9

Cipro

Orange BookUNIISPLATC J01MA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01MA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5041975801
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-758-01)

Annotations

UNII (FDA Substance ID)
4BA73M5E37
CIPROFLOXACIN HYDROCHLORIDE
RxCUI 81981
Orange Book
N019537
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": {
    "888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0": {
      "match": "brand_token",
      "title": "CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "32",
      "published_date": "2026-03-04"
    }
  },
  "productid": "50419-758_1b112839-6cf0-466a-9188-86fc5b1549f9",
  "productndc": "50419-758",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "019537",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "002",
        "approval_date": "Oct 22, 1987"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "003",
        "approval_date": "Oct 22, 1987"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Oct 22, 1987"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPROFLOXACIN HYDROCHLORIDE",
  "proprietary_name": "Cipro",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019537",
  "marketing_category": "NDA",
  "nonproprietary_name": "ciprofloxacin hydrochloride",
  "start_marketing_date": "19871022",
  "active_numerator_strength": "250"
}

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