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United States · US · US:76420-588_045968a3-3bad-28cf-e063-6394a90a4fe1

ciprofloxacin

Orange BookUNIISPLATC J01MA02

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

Identification

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

Packs · 3

  • ndc11
    7642058802
    1 BOTTLE, PLASTIC in 1 CARTON (76420-588-02) / 2.5 mL in 1 BOTTLE, PLASTIC
  • ndc11
    7642058805
    1 BOTTLE, PLASTIC in 1 CARTON (76420-588-05) / 5 mL in 1 BOTTLE, PLASTIC
  • ndc11
    7642058810
    1 BOTTLE, PLASTIC in 1 CARTON (76420-588-10) / 10 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
4BA73M5E37
CIPROFLOXACIN HYDROCHLORIDE
RxCUI 81981
Orange Book
A077568
AT
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": "OPHTHALMIC",
  "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": "76420-588_045968a3-3bad-28cf-e063-6394a90a4fe1",
  "productndc": "76420-588",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "077568",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "EQ 0.3% BASE",
        "product_no": "001",
        "approval_date": "Jun 30, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPROFLOXACIN HYDROCHLORIDE",
  "proprietary_name": "ciprofloxacin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA077568",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciprofloxacin",
  "start_marketing_date": "20181101",
  "active_numerator_strength": "3"
}

Related drugs

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