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United States · US · US:68071-4512_1a907884-caea-cc4d-e063-6394a90acac4

Levofloxacin

Orange BookUNIISPLATC J01MA12

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

Identification

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

Packs · 3

  • ndc11
    6807145121
    1 TABLET, FILM COATED in 1 BOTTLE (68071-4512-1)
  • ndc11
    6807145122
    2 TABLET, FILM COATED in 1 BOTTLE (68071-4512-2)
  • ndc11
    6807145123
    3 TABLET, FILM COATED in 1 BOTTLE (68071-4512-3)

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": "68071-4512_1a907884-caea-cc4d-e063-6394a90acac4",
  "productndc": "68071-4512",
  "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"
}

Related drugs

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