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United States · US · US:71335-0593_50fbb1d6-bfc6-4472-b047-fde1564f2530

Levofloxacin

Orange BookUNIISPLATC J01MA12

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ01MA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    7133505931
    10 TABLET, FILM COATED in 1 BOTTLE (71335-0593-1)
  • ndc11
    7133505932
    30 TABLET, FILM COATED in 1 BOTTLE (71335-0593-2)
  • ndc11
    7133505933
    7 TABLET, FILM COATED in 1 BOTTLE (71335-0593-3)
  • ndc11
    7133505934
    20 TABLET, FILM COATED in 1 BOTTLE (71335-0593-4)
  • ndc11
    7133505935
    5 TABLET, FILM COATED in 1 BOTTLE (71335-0593-5)
  • ndc11
    7133505936
    14 TABLET, FILM COATED in 1 BOTTLE (71335-0593-6)
  • ndc11
    7133505937
    28 TABLET, FILM COATED in 1 BOTTLE (71335-0593-7)
  • ndc11
    7133505938
    60 TABLET, FILM COATED in 1 BOTTLE (71335-0593-8)
  • ndc11
    7133505939
    90 TABLET, FILM COATED in 1 BOTTLE (71335-0593-9)

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": "71335-0593_50fbb1d6-bfc6-4472-b047-fde1564f2530",
  "productndc": "71335-0593",
  "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": "20150109",
  "active_numerator_strength": "750"
}

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