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United States · US · US:63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9

Ciprofloxacin

Orange BookUNIISPLATC J01MA02

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ01MA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    6362910101
    100 TABLET, FILM COATED in 1 BOTTLE (63629-1010-1)
  • ndc11
    6362910102
    20 TABLET, FILM COATED in 1 BOTTLE (63629-1010-2)
  • ndc11
    6362910103
    30 TABLET, FILM COATED in 1 BOTTLE (63629-1010-3)
  • ndc11
    6362910104
    14 TABLET, FILM COATED in 1 BOTTLE (63629-1010-4)
  • ndc11
    6362910105
    500 TABLET, FILM COATED in 1 BOTTLE (63629-1010-5)
  • ndc11
    6362910106
    60 TABLET, FILM COATED in 1 BOTTLE (63629-1010-6)
  • ndc11
    6362910107
    10 TABLET, FILM COATED in 1 BOTTLE (63629-1010-7)
  • ndc11
    6362910108
    120 TABLET, FILM COATED in 1 BOTTLE (63629-1010-8)

Annotations

UNII (FDA Substance ID)
4BA73M5E37
CIPROFLOXACIN HYDROCHLORIDE
RxCUI 81981
Orange Book
A076126
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": "63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9",
  "productndc": "63629-1010",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076126",
    "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076126",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciprofloxacin Hydrochloride",
  "start_marketing_date": "20091010",
  "active_numerator_strength": "500"
}

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