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United States · US · US:72189-334_2c3d95a4-32d2-ef3b-e063-6294a90ac144
MOXIFLOXACIN
In shortageOrange BookUNIISPLATC J01MA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect Rx
CountryUS (United States)
ATC codeJ01MA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172189334053 mL in 1 BOTTLE (72189-334-05)
Annotations
UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
A202916
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": "72189-334_2c3d95a4-32d2-ef3b-e063-6294a90ac144",
"productndc": "72189-334",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "202916",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Nov 9, 2017"
}
],
"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": "ANDA202916",
"marketing_category": "ANDA",
"nonproprietary_name": "MOXIFLOXACIN",
"start_marketing_date": "20220308",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code J01MA14.
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