Levofloxacin

Orange BookUNIISPLATC J01MA12

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeJ01MA12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143931624
24 BAG in 1 CARTON (0143-9316-24) / 100 mL in 1 BAG (0143-9316-01)

Annotations

UNII (FDA Substance ID)

6GNT3Y5LMF

LEVOFLOXACIN

RxCUI 82122

Orange Book

A091375

APAPAP

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": "INTRAVENOUS",
  "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": "0143-9316_05cdb9d7-2bce-400d-8565-8a76c4a1a8e3",
  "productndc": "0143-9316",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "091375",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 250MG/50ML (EQ 5MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 16, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG/100ML (EQ 5MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 16, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 750MG/150ML (EQ 5MG/ML)",
        "product_no": "003",
        "approval_date": "Sep 16, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOFLOXACIN",
  "proprietary_name": "Levofloxacin",
  "active_ingred_unit": "mg/100mL",
  "application_number": "ANDA091375",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levofloxacin",
  "start_marketing_date": "20110916",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01MA12.

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