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United States · US · US:68788-8136_e6e1419a-65f6-42a7-a4f9-67a2fdf7aa53

Ciprofloxacin

Orange BookUNIISPLATC J01MA02

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

Identification

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

Packs · 5

  • ndc11
    6878881360
    6 TABLET, FILM COATED in 1 BOTTLE (68788-8136-0)
  • ndc11
    6878881361
    14 TABLET, FILM COATED in 1 BOTTLE (68788-8136-1)
  • ndc11
    6878881362
    20 TABLET, FILM COATED in 1 BOTTLE (68788-8136-2)
  • ndc11
    6878881363
    30 TABLET, FILM COATED in 1 BOTTLE (68788-8136-3)
  • ndc11
    6878881368
    10 TABLET, FILM COATED in 1 BOTTLE (68788-8136-8)

Annotations

UNII (FDA Substance ID)
4BA73M5E37
CIPROFLOXACIN HYDROCHLORIDE
RxCUI 81981
Orange Book
A077859
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": "68788-8136_e6e1419a-65f6-42a7-a4f9-67a2fdf7aa53",
  "productndc": "68788-8136",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077859",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Apr 26, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Apr 26, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 750MG BASE",
        "product_no": "003",
        "approval_date": "Apr 26, 2007"
      }
    ],
    "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": "ANDA077859",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciprofloxacin Hydrochloride",
  "start_marketing_date": "20220203",
  "active_numerator_strength": "500"
}

Related drugs

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