Levofloxacin

Orange BookUNIISPLATC J01MA12

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeJ01MA12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7120500203
3 TABLET, FILM COATED in 1 BOTTLE (71205-002-03)
ndc11
7120500205
5 TABLET, FILM COATED in 1 BOTTLE (71205-002-05)
ndc11
7120500207
7 TABLET, FILM COATED in 1 BOTTLE (71205-002-07)
ndc11
7120500210
10 TABLET, FILM COATED in 1 BOTTLE (71205-002-10)
ndc11
7120500212
12 TABLET, FILM COATED in 1 BOTTLE (71205-002-12)
ndc11
7120500214
14 TABLET, FILM COATED in 1 BOTTLE (71205-002-14)
ndc11
7120500221
21 TABLET, FILM COATED in 1 BOTTLE (71205-002-21)

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": "71205-002_a630f88d-800c-400f-9da4-1b26c0ee1f85",
  "productndc": "71205-002",
  "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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