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United States · US · US:62756-427_4ba06043-b13f-42fe-a398-fe7e7b84163e

Ciprofloxacin and dexamethasone

Orange BookUNIISPLATC J01MA

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeJ01MA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6275642790
    1 BOTTLE, DROPPER in 1 CARTON (62756-427-90) / 7.5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
4BA73M5E37
CIPROFLOXACIN HYDROCHLORIDE
RxCUI 81981
Orange Book
A210470
AB
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": "AURICULAR (OTIC)",
  "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": "62756-427_4ba06043-b13f-42fe-a398-fe7e7b84163e",
  "productndc": "62756-427",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "210470",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.3%;0.1%",
        "product_no": "001",
        "approval_date": "Aug 30, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE",
  "proprietary_name": "Ciprofloxacin and dexamethasone",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA210470",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ciprofloxacin and dexamethasone",
  "start_marketing_date": "20220901",
  "active_numerator_strength": "3; 1"
}

Related drugs

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