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United States · US · US:68788-6938_7b2e4ded-642b-4cee-b6a1-5a5e6416ca78

Levofloxacin

Orange BookUNIISPLATC J01MA12

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

Identification

ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01MA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6878869381
    10 TABLET, FILM COATED in 1 BOTTLE (68788-6938-1)
  • ndc11
    6878869382
    20 TABLET, FILM COATED in 1 BOTTLE (68788-6938-2)
  • ndc11
    6878869384
    14 TABLET, FILM COATED in 1 BOTTLE (68788-6938-4)
  • ndc11
    6878869387
    7 TABLET, FILM COATED in 1 BOTTLE (68788-6938-7)

Annotations

UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A202801
ABABAB
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": "ORAL",
  "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": "68788-6938_7b2e4ded-642b-4cee-b6a1-5a5e6416ca78",
  "productndc": "68788-6938",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202801",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jan 8, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jan 8, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "003",
        "approval_date": "Jan 8, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOFLOXACIN",
  "proprietary_name": "Levofloxacin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202801",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levofloxacin",
  "start_marketing_date": "20170404",
  "active_numerator_strength": "500"
}

Related drugs

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