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United States · US · US:70518-0719_48332f2b-f97c-f9fd-e063-6394a90affa8

Levofloxacin

Orange BookUNIISPLATC J01MA12

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ01MA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051807190
    30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0719-0)

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": "70518-0719_48332f2b-f97c-f9fd-e063-6394a90affa8",
  "productndc": "70518-0719",
  "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": "20170830",
  "active_numerator_strength": "250"
}

Related drugs

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