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United States · US · US:76420-815_184fff28-0fd3-da61-e063-6294a90ac035
Levofloxacin
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc1176420815001000 TABLET, FILM COATED in 1 BOTTLE (76420-815-00)
- ndc1176420815055 TABLET, FILM COATED in 1 BOTTLE (76420-815-05)
- ndc1176420815077 TABLET, FILM COATED in 1 BOTTLE (76420-815-07)
- ndc11764208151010 TABLET, FILM COATED in 1 BOTTLE (76420-815-10)
- ndc11764208151414 TABLET, FILM COATED in 1 BOTTLE (76420-815-14)
- ndc11764208152020 TABLET, FILM COATED in 1 BOTTLE (76420-815-20)
- ndc11764208153030 TABLET, FILM COATED in 1 BOTTLE (76420-815-30)
- ndc11764208155050 TABLET, FILM COATED in 1 BOTTLE (76420-815-50)
- ndc11764208156060 TABLET, FILM COATED in 1 BOTTLE (76420-815-60)
- ndc11764208159090 TABLET, FILM COATED in 1 BOTTLE (76420-815-90)
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A201043
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": "76420-815_184fff28-0fd3-da61-e063-6294a90ac035",
"productndc": "76420-815",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "201043",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "001",
"approval_date": "Jun 20, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "002",
"approval_date": "Jun 20, 2011"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "003",
"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/1",
"application_number": "ANDA201043",
"marketing_category": "ANDA",
"nonproprietary_name": "Levofloxacin",
"start_marketing_date": "20110620",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code J01MA12.
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