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United States · US · US:68180-421_29272b83-77cf-4cd1-9aed-b80d0cc6edb5
MOXIFLOXACIN
In shortageOrange BookUNIISPLATC J01MA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01MA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168180421013 mL in 1 BOTTLE (68180-421-01)
Annotations
UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
A204079
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": "OPHTHALMIC",
"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": "68180-421_29272b83-77cf-4cd1-9aed-b80d0cc6edb5",
"productndc": "68180-421",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "204079",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "May 28, 2015"
}
],
"appl_type": "A"
},
"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/mL",
"application_number": "ANDA204079",
"marketing_category": "ANDA",
"nonproprietary_name": "MOXIFLOXACIN",
"start_marketing_date": "20200213",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code J01MA14.
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