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United States · US · US:72888-142_2ffa08e2-0405-47bb-e063-6294a90a4fe0

LEVOFLOXACIN

Orange BookUNIISPLATC J01MA12

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

Identification

ManufacturerAdvagen Pharma Limited
CountryUS (United States)
ATC codeJ01MA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7288814222
    1 BOTTLE in 1 CARTON (72888-142-22) / 5 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A078282
AT
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": "72888-142_2ffa08e2-0405-47bb-e063-6294a90a4fe0",
  "productndc": "72888-142",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "078282",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Dec 20, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOFLOXACIN",
  "proprietary_name": "LEVOFLOXACIN",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078282",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEVOFLOXACIN",
  "start_marketing_date": "20220222",
  "active_numerator_strength": "5"
}

Related drugs

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