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United States · US · US:63187-833_e5c99469-b1e5-4f86-b4fa-7fcb4eac8f46
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 · 6
- ndc1163187833055 TABLET, FILM COATED in 1 BOTTLE (63187-833-05)
- ndc1163187833077 TABLET, FILM COATED in 1 BOTTLE (63187-833-07)
- ndc11631878331010 TABLET, FILM COATED in 1 BOTTLE (63187-833-10)
- ndc11631878333030 TABLET, FILM COATED in 1 BOTTLE (63187-833-30)
- ndc11631878336060 TABLET, FILM COATED in 1 BOTTLE (63187-833-60)
- ndc11631878339090 TABLET, FILM COATED in 1 BOTTLE (63187-833-90)
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A202801
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": "63187-833_e5c99469-b1e5-4f86-b4fa-7fcb4eac8f46",
"productndc": "63187-833",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202801",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Jan 8, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Jan 8, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"approval_date": "Jan 8, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOFLOXACIN",
"proprietary_name": "Levofloxacin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202801",
"marketing_category": "ANDA",
"nonproprietary_name": "Levofloxacin",
"start_marketing_date": "20150109",
"active_numerator_strength": "750"
}Related drugs
Other records sharing ATC code J01MA12.
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