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United States · US · US:70954-852_b548d9b8-70c9-41d4-8103-41568d50f561
Levofloxacin
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117095485210100 mL in 1 BOTTLE (70954-852-10)
- ndc117095485220200 mL in 1 BOTTLE (70954-852-20)
- ndc117095485230480 mL in 1 BOTTLE (70954-852-30)
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A091678
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": "70954-852_b548d9b8-70c9-41d4-8103-41568d50f561",
"productndc": "70954-852",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "091678",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "250MG/10ML",
"product_no": "001",
"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/mL",
"application_number": "ANDA091678",
"marketing_category": "ANDA",
"nonproprietary_name": "Levofloxacin",
"start_marketing_date": "20240326",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code J01MA12.
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