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United States · US · US:54288-140_4c9a6374-9e83-420d-bc29-20170bfbc6e1

Levofloxacin

Orange BookUNIISPLATC J01MA12

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

Identification

ManufacturerBPI LABS LLC
CountryUS (United States)
ATC codeJ01MA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5428814001
    1 CARTON in 1 CARTON (54288-140-01) / 5 mL in 1 CARTON

Annotations

UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A205600
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6GNT3Y5LMF",
    "rxcui": "82122",
    "inchikey": "SUIQUYDRLGGZOL-RCWTXCDDSA-N",
    "display_name": "LEVOFLOXACIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "070375be-3b67-4299-ae8f-4a7b157ac16f": {
      "match": "brand_token",
      "title": "LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
      "spl_version": "19",
      "published_date": "2026-06-01"
    }
  },
  "productid": "54288-140_4c9a6374-9e83-420d-bc29-20170bfbc6e1",
  "productndc": "54288-140",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "205600",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.5%",
        "product_no": "001",
        "approval_date": "Feb 27, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOFLOXACIN",
  "proprietary_name": "Levofloxacin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA205600",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levofloxacin",
  "start_marketing_date": "20200713",
  "active_numerator_strength": "15"
}

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