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United States · US · US:76420-817_184fff28-0fd3-da61-e063-6294a90ac035

Levofloxacin

Orange BookUNIISPLATC J01MA12

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

Identification

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

Packs · 10

  • ndc11
    7642081705
    5 TABLET, FILM COATED in 1 BOTTLE (76420-817-05)
  • ndc11
    7642081707
    7 TABLET, FILM COATED in 1 BOTTLE (76420-817-07)
  • ndc11
    7642081710
    10 TABLET, FILM COATED in 1 BOTTLE (76420-817-10)
  • ndc11
    7642081714
    14 TABLET, FILM COATED in 1 BOTTLE (76420-817-14)
  • ndc11
    7642081720
    20 TABLET, FILM COATED in 1 BOTTLE (76420-817-20)
  • ndc11
    7642081730
    30 TABLET, FILM COATED in 1 BOTTLE (76420-817-30)
  • ndc11
    7642081750
    50 TABLET, FILM COATED in 1 BOTTLE (76420-817-50)
  • ndc11
    7642081755
    500 TABLET, FILM COATED in 1 BOTTLE (76420-817-55)
  • ndc11
    7642081760
    60 TABLET, FILM COATED in 1 BOTTLE (76420-817-60)
  • ndc11
    7642081790
    90 TABLET, FILM COATED in 1 BOTTLE (76420-817-90)

Annotations

UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A201043
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": "76420-817_184fff28-0fd3-da61-e063-6294a90ac035",
  "productndc": "76420-817",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201043",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jun 20, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jun 20, 2011"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "003",
        "approval_date": "Jun 20, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOFLOXACIN",
  "proprietary_name": "Levofloxacin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201043",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levofloxacin",
  "start_marketing_date": "20110620",
  "active_numerator_strength": "750"
}

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