Levofloxacin

Orange BookUNIISPLATC J01MA12

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

Identification

ManufacturerEugia US LLC

CountryUS (United States)

ATC codeJ01MA12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5515015730
1 VIAL, SINGLE-USE in 1 CARTON (55150-157-30) / 30 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

6GNT3Y5LMF

LEVOFLOXACIN

RxCUI 82122

Orange Book

A202328

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": "55150-157_2a91fee4-6952-42e2-8326-c2d4233d11d3",
  "productndc": "55150-157",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "202328",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 500MG/20ML (EQ 25MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 24, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 750MG/30ML (EQ 25MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 24, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOFLOXACIN",
  "proprietary_name": "Levofloxacin",
  "active_ingred_unit": "mg/30mL",
  "application_number": "ANDA202328",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levofloxacin",
  "start_marketing_date": "20130124",
  "active_numerator_strength": "750"
}

Related drugs

Other records sharing ATC code J01MA12.

Access this data programmatically

Query Levofloxacin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs