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United States · US · US:0527-1948_01e976a4-eb3a-4d1a-a384-46222c20afc5
Levofloxacin
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1105271948661 BOTTLE, PLASTIC in 1 CARTON (0527-1948-66) / 100 mL in 1 BOTTLE, PLASTIC
- ndc1105271948681 BOTTLE, PLASTIC in 1 CARTON (0527-1948-68) / 200 mL in 1 BOTTLE, PLASTIC
- ndc1105271948701 BOTTLE, PLASTIC in 1 CARTON (0527-1948-70) / 480 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A205222
AA
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": "0527-1948_01e976a4-eb3a-4d1a-a384-46222c20afc5",
"productndc": "0527-1948",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "205222",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "250MG/10ML",
"product_no": "001",
"approval_date": "May 25, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOFLOXACIN",
"proprietary_name": "Levofloxacin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA205222",
"marketing_category": "ANDA",
"nonproprietary_name": "Levofloxacin",
"start_marketing_date": "20180525",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code J01MA12.
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