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United States · US · US:55111-280_c51f53eb-2f01-93dc-e7e6-695b20b639ce
Levofloxacin
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc115511128001100 TABLET, FILM COATED in 1 BOTTLE (55111-280-01)
- ndc115511128005500 TABLET, FILM COATED in 1 BOTTLE (55111-280-05)
- ndc11551112803030 TABLET, FILM COATED in 1 BOTTLE (55111-280-30)
- ndc11551112805050 TABLET, FILM COATED in 1 BOTTLE (55111-280-50)
- ndc11551112807810 BLISTER PACK in 1 CARTON (55111-280-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-280-79)
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A076710
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": "55111-280_c51f53eb-2f01-93dc-e7e6-695b20b639ce",
"productndc": "55111-280",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "076710",
"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": false,
"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": "ANDA076710",
"marketing_category": "ANDA",
"nonproprietary_name": "Levofloxacin",
"start_marketing_date": "20110620",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01MA12.
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