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United States · US · US:68083-395_949f1c99-7067-450e-bc22-504f5aed0de9
LEVOFLOXACIN
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083395011 VIAL, SINGLE-DOSE in 1 CARTON (68083-395-01) / 30 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A205540
APAP
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": "68083-395_949f1c99-7067-450e-bc22-504f5aed0de9",
"productndc": "68083-395",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "205540",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG/20ML (EQ 25MG/ML)",
"product_no": "001",
"approval_date": "Apr 22, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 750MG/30ML (EQ 25MG/ML)",
"product_no": "002",
"approval_date": "Apr 22, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOFLOXACIN",
"proprietary_name": "LEVOFLOXACIN",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA205540",
"marketing_category": "ANDA",
"nonproprietary_name": "LEVOFLOXACIN",
"start_marketing_date": "20200422",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code J01MA12.
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