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United States · US · US:62332-505_57885d05-de45-4be8-b01d-d3596fb8a96d
Moxifloxacin ophthalmic solution
In shortageOrange BookUNIISPLATC J01MA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01MA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1162332505031 BOTTLE in 1 CARTON (62332-505-03) / 3 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
A209469
AT1
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": "62332-505_57885d05-de45-4be8-b01d-d3596fb8a96d",
"productndc": "62332-505",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "209469",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT1",
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Feb 13, 2019"
}
],
"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 ophthalmic solution",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA209469",
"marketing_category": "ANDA",
"nonproprietary_name": "Moxifloxacin ophthalmic solution",
"start_marketing_date": "20190213",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code J01MA14.
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