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United States · US · US:25021-132_364ea810-a100-4a99-9a82-144a30e96572
Levofloxacin
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11250211328124 POUCH in 1 CARTON (25021-132-81) / 1 BAG in 1 POUCH / 50 mL in 1 BAG
- ndc11250211328224 POUCH in 1 CARTON (25021-132-82) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
- ndc11250211328324 POUCH in 1 CARTON (25021-132-83) / 1 BAG in 1 POUCH / 150 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A090343
APAPAP
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": "INTRAVENOUS",
"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": "25021-132_364ea810-a100-4a99-9a82-144a30e96572",
"productndc": "25021-132",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "090343",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG/50ML (EQ 5MG/ML)",
"product_no": "001",
"approval_date": "Jul 7, 2011"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG/100ML (EQ 5MG/ML)",
"product_no": "002",
"approval_date": "Jul 7, 2011"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 750MG/150ML (EQ 5MG/ML)",
"product_no": "003",
"approval_date": "Jul 7, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOFLOXACIN",
"proprietary_name": "Levofloxacin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA090343",
"marketing_category": "ANDA",
"nonproprietary_name": "Levofloxacin",
"start_marketing_date": "20110620",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code J01MA12.
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