🇺🇸
United States · US · US:61919-426_4f5b83f6-1a34-21ec-e063-6294a90a4560
LEVOFLOXACIN
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDIRECT RX
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1161919426077 TABLET, FILM COATED in 1 BOTTLE (61919-426-07)
- ndc11619194261010 TABLET, FILM COATED in 1 BOTTLE (61919-426-10)
- ndc11619194261414 TABLET, FILM COATED in 1 BOTTLE (61919-426-14)
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A202801
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": "61919-426_4f5b83f6-1a34-21ec-e063-6294a90a4560",
"productndc": "61919-426",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202801",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Jan 8, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Jan 8, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"approval_date": "Jan 8, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOFLOXACIN",
"proprietary_name": "LEVOFLOXACIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202801",
"marketing_category": "ANDA",
"nonproprietary_name": "LEVOFLOXACIN",
"start_marketing_date": "20190424",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01MA12.
Access this data programmatically
Query LEVOFLOXACIN and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.