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United States · US · US:59390-140_28125c1a-d1b0-4763-9b5e-07b4cfc2d889

Ofloxacin ophthalmic

Orange BookUNIISPLATC J01MA01

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

Identification

ManufacturerAltaire Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01MA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5939014005
    5 mL in 1 BOTTLE, DROPPER (59390-140-05)

Annotations

UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A202692
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "A4P49JAZ9H",
    "rxcui": "7623",
    "inchikey": "GSDSWSVVBLHKDQ-UHFFFAOYSA-N",
    "display_name": "OFLOXACIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "d97651cc-d9ea-4be4-8ea1-3d0278582dd5": {
      "match": "brand_token",
      "title": "OFLOXACIN SOLUTION/ DROPS [REMEDYREPACK INC.]",
      "spl_version": "7",
      "published_date": "2026-04-17"
    }
  },
  "productid": "59390-140_28125c1a-d1b0-4763-9b5e-07b4cfc2d889",
  "productndc": "59390-140",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "202692",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.3%",
        "product_no": "001",
        "approval_date": "Apr 29, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OFLOXACIN",
  "proprietary_name": "Ofloxacin ophthalmic",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA202692",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ofloxacin",
  "start_marketing_date": "20130531",
  "active_numerator_strength": "3"
}

Related drugs

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