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United States · US · US:65841-693_5aeae448-e53f-4954-9dd9-2bcc3dd791d4

levofloxacin

Orange BookUNIISPLATC J01MA12

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeJ01MA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6584169301
    100 TABLET, FILM COATED in 1 BOTTLE (65841-693-01)
  • ndc11
    6584169305
    500 TABLET, FILM COATED in 1 BOTTLE (65841-693-05)
  • ndc11
    6584169306
    30 TABLET, FILM COATED in 1 BOTTLE (65841-693-06)
  • ndc11
    6584169318
    50 TABLET, FILM COATED in 1 BOTTLE (65841-693-18)
  • ndc11
    6584169392
    20 TABLET, FILM COATED in 1 BOTTLE (65841-693-92)

Annotations

UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A077652
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": "65841-693_5aeae448-e53f-4954-9dd9-2bcc3dd791d4",
  "productndc": "65841-693",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077652",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Sep 7, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Sep 7, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "003",
        "approval_date": "Sep 7, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOFLOXACIN",
  "proprietary_name": "levofloxacin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077652",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levofloxacin",
  "start_marketing_date": "20121110",
  "active_numerator_strength": "750"
}

Related drugs

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