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United States · US · US:36000-045_3cbc7b81-fabf-4666-951c-76f19e4f3222

Levofloxacin

Orange BookUNIISPLATC J01MA12

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeJ01MA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3600004501
    20 mL in 1 VIAL, SINGLE-USE (36000-045-01)

Annotations

UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A091436
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": "INTRAVENOUS",
  "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": "36000-045_3cbc7b81-fabf-4666-951c-76f19e4f3222",
  "productndc": "36000-045",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "091436",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 500MG/20ML (EQ 25MG/ML)",
        "product_no": "001",
        "approval_date": "Jun 5, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOFLOXACIN",
  "proprietary_name": "Levofloxacin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA091436",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levofloxacin",
  "start_marketing_date": "20130701",
  "active_numerator_strength": "25"
}

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