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United States · US · US:71205-058_7dd77e34-db22-4496-9150-19d9c37b45b4
Levofloxacin
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11712050582121 TABLET, FILM COATED in 1 BOTTLE (71205-058-21)
- ndc11712050583030 TABLET, FILM COATED in 1 BOTTLE (71205-058-30)
- ndc11712050586060 TABLET, FILM COATED in 1 BOTTLE (71205-058-60)
- ndc11712050589090 TABLET, FILM COATED in 1 BOTTLE (71205-058-90)
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": "71205-058_7dd77e34-db22-4496-9150-19d9c37b45b4",
"productndc": "71205-058",
"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": "250"
}Related drugs
Other records sharing ATC code J01MA12.
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