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United States · US · US:72578-100_6295ff00-86a9-454c-987b-a1fe1c4386e8
levofloxacin
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117257810001100 TABLET, FILM COATED in 1 BOTTLE (72578-100-01)
- ndc117257810005500 TABLET, FILM COATED in 1 BOTTLE (72578-100-05)
- ndc11725781000630 TABLET, FILM COATED in 1 BOTTLE (72578-100-06)
- ndc11725781001850 TABLET, FILM COATED in 1 BOTTLE (72578-100-18)
- ndc11725781009220 TABLET, FILM COATED in 1 BOTTLE (72578-100-92)
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A077652
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": "72578-100_6295ff00-86a9-454c-987b-a1fe1c4386e8",
"productndc": "72578-100",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077652",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Sep 7, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Sep 7, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"approval_date": "Sep 7, 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": "ANDA077652",
"marketing_category": "ANDA",
"nonproprietary_name": "levofloxacin",
"start_marketing_date": "20220110",
"active_numerator_strength": "750"
}Related drugs
Other records sharing ATC code J01MA12.
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