Levofloxacin

Orange BookUNIISPLATC J01MA12

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerWG Critical Care, LLC

CountryUS (United States)

ATC codeJ01MA12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4456743724
24 POUCH in 1 CARTON (44567-437-24) / 1 BAG in 1 POUCH / 150 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

6GNT3Y5LMF

LEVOFLOXACIN

RxCUI 82122

Orange Book

A090343

APAPAP

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": "44567-437_e6bfbccc-f54c-4d4d-b268-b4fc803e372b",
  "productndc": "44567-437",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "090343",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 250MG/50ML (EQ 5MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 7, 2011"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG/100ML (EQ 5MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 7, 2011"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 750MG/150ML (EQ 5MG/ML)",
        "product_no": "003",
        "approval_date": "Jul 7, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOFLOXACIN",
  "proprietary_name": "Levofloxacin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090343",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levofloxacin",
  "start_marketing_date": "20160414",
  "active_numerator_strength": "5"
}

Related drugs

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