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United States · US · US:63187-662_78fd4254-2047-414b-ab00-68d3427a3261

Ofloxacin

Orange BookUNIISPLATC J01MA01

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01MA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6318766205
    1 BOTTLE, DROPPER in 1 CARTON (63187-662-05) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    6318766210
    1 BOTTLE, DROPPER in 1 CARTON (63187-662-10) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A076407
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": "63187-662_78fd4254-2047-414b-ab00-68d3427a3261",
  "productndc": "63187-662",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "076407",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.3%",
        "product_no": "001",
        "approval_date": "Apr 15, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OFLOXACIN",
  "proprietary_name": "Ofloxacin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA076407",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ofloxacin",
  "start_marketing_date": "20080701",
  "active_numerator_strength": "3"
}

Related drugs

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