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United States · US · US:63323-355_d2cd980c-648b-4efd-b39d-49c8e0f8f9b9
Levofloxacin
Orange BookUNIISPLATC J01MA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01MA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1163323355501 BAG in 1 POUCH (63323-355-50) / 50 mL in 1 BAG
- ndc1163323355601 BAG in 1 POUCH (63323-355-60) / 150 mL in 1 BAG
- ndc1163323355651 BAG in 1 POUCH (63323-355-65) / 100 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
6GNT3Y5LMF
LEVOFLOXACIN
RxCUI 82122
Orange Book
A200674
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": "63323-355_d2cd980c-648b-4efd-b39d-49c8e0f8f9b9",
"productndc": "63323-355",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "200674",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG/50ML (EQ 5MG/ML)",
"product_no": "001",
"approval_date": "Jun 19, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG/100ML (EQ 5MG/ML)",
"product_no": "002",
"approval_date": "Jun 19, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 750MG/150ML (EQ 5MG/ML)",
"product_no": "003",
"approval_date": "Jun 19, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOFLOXACIN",
"proprietary_name": "Levofloxacin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA200674",
"marketing_category": "ANDA",
"nonproprietary_name": "LEVOFLOXACIN",
"start_marketing_date": "20130620",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code J01MA12.
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