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United States · US · US:63323-850_4070f637-059f-4e3d-8cf3-e5256a46ff3e
Moxifloxacin
In shortageOrange BookUNIISPLATC J01MA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01MA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633238500412 BAG in 1 CASE (63323-850-04) / 250 mL in 1 BAG (63323-850-74)
Annotations
UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
N205572
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Moxifloxacin Injection
Raw payload (JSON)
{
"unii": {
"unii": "C53598599T",
"rxcui": "228750",
"inchikey": "IDIIJJHBXUESQI-DFIJPDEKSA-N",
"display_name": "MOXIFLOXACIN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"c6fa4129-2f92-4179-ac5d-bb7b4a538789": {
"match": "brand_token",
"title": "MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
"spl_version": "9",
"published_date": "2026-05-21"
}
},
"productid": "63323-850_4070f637-059f-4e3d-8cf3-e5256a46ff3e",
"productndc": "63323-850",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "205572",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)",
"product_no": "001",
"approval_date": "Apr 3, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MOXIFLOXACIN HYDROCHLORIDE",
"shortage_reason": "Moxifloxacin Injection",
"shortage_status": "current",
"proprietary_name": "Moxifloxacin",
"active_ingred_unit": "mg/250mL",
"application_number": "NDA205572",
"marketing_category": "NDA",
"nonproprietary_name": "MOXIFLOXACIN HYDROCHLORIDE",
"start_marketing_date": "20150318",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J01MA14.
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