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United States · US · US:33342-531_fc165a6d-24b0-4753-a7ac-94a134dca0d3
Levofloxacin
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11333425310850 TABLET, FILM COATED in 1 BOTTLE (33342-531-08)
- ndc113334253111100 TABLET, FILM COATED in 1 BOTTLE (33342-531-11)
- ndc113334253112100 TABLET, FILM COATED in 1 BLISTER PACK (33342-531-12)
- ndc11333425313150 TABLET, FILM COATED in 1 BLISTER PACK (33342-531-31)
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A200839
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": "33342-531_fc165a6d-24b0-4753-a7ac-94a134dca0d3",
"productndc": "33342-531",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "200839",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Mar 22, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Mar 22, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"approval_date": "Mar 22, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOFLOXACIN",
"proprietary_name": "Levofloxacin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA200839",
"marketing_category": "ANDA",
"nonproprietary_name": "Levofloxacin",
"start_marketing_date": "20120322",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01MA12.
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