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United States · US · US:71335-0434_fb951968-65db-479b-b313-2ac274ea0df2

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 · 10

  • ndc11
    7133504340
    90 TABLET, FILM COATED in 1 BOTTLE (71335-0434-0)
  • ndc11
    7133504341
    30 TABLET, FILM COATED in 1 BOTTLE (71335-0434-1)
  • ndc11
    7133504342
    10 TABLET, FILM COATED in 1 BOTTLE (71335-0434-2)
  • ndc11
    7133504343
    7 TABLET, FILM COATED in 1 BOTTLE (71335-0434-3)
  • ndc11
    7133504344
    14 TABLET, FILM COATED in 1 BOTTLE (71335-0434-4)
  • ndc11
    7133504345
    5 TABLET, FILM COATED in 1 BOTTLE (71335-0434-5)
  • ndc11
    7133504346
    20 TABLET, FILM COATED in 1 BOTTLE (71335-0434-6)
  • ndc11
    7133504347
    60 TABLET, FILM COATED in 1 BOTTLE (71335-0434-7)
  • ndc11
    7133504348
    3 TABLET, FILM COATED in 1 BOTTLE (71335-0434-8)
  • ndc11
    7133504349
    50 TABLET, FILM COATED in 1 BOTTLE (71335-0434-9)

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": "71335-0434_fb951968-65db-479b-b313-2ac274ea0df2",
  "productndc": "71335-0434",
  "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": "500"
}

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