levofloxacin

Orange BookUNIISPLATC J01MA12

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeJ01MA12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808341601
1 BAG in 1 POUCH (68083-416-01) / 150 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

6GNT3Y5LMF

LEVOFLOXACIN

RxCUI 82122

Orange Book

A206908

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": "68083-416_7df12e53-0519-4d42-b89f-dbe83b7e7e7d",
  "productndc": "68083-416",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "206908",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 250MG/50ML (EQ 5MG/ML)",
        "product_no": "001",
        "approval_date": "Dec 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG/100ML (EQ 5MG/ML)",
        "product_no": "002",
        "approval_date": "Dec 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 750MG/150ML (EQ 5MG/ML)",
        "product_no": "003",
        "approval_date": "Dec 30, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOFLOXACIN",
  "proprietary_name": "levofloxacin",
  "active_ingred_unit": "mg/150mL",
  "application_number": "ANDA206908",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levofloxacin",
  "start_marketing_date": "20201230",
  "active_numerator_strength": "750"
}

Related drugs

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