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United States · US · US:54288-140_4c9a6374-9e83-420d-bc29-20170bfbc6e1
Levofloxacin
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBPI LABS LLC
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1154288140011 CARTON in 1 CARTON (54288-140-01) / 5 mL in 1 CARTON
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A205600
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": "OPHTHALMIC",
"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": "54288-140_4c9a6374-9e83-420d-bc29-20170bfbc6e1",
"productndc": "54288-140",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "205600",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1.5%",
"product_no": "001",
"approval_date": "Feb 27, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOFLOXACIN",
"proprietary_name": "Levofloxacin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA205600",
"marketing_category": "ANDA",
"nonproprietary_name": "Levofloxacin",
"start_marketing_date": "20200713",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code J01MA12.
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