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United States · US · US:76420-331_331b69c5-5ad7-a90a-e063-6394a90acfd6
Moxifloxacin Hydrochloride
In shortageOrange BookUNIISPLATC J01MA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeJ01MA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1176420331031 BOTTLE, PLASTIC in 1 CARTON (76420-331-03) / 3 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
A212616
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": "76420-331_331b69c5-5ad7-a90a-e063-6394a90acfd6",
"productndc": "76420-331",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "212616",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT1",
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Feb 10, 2021"
}
],
"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 Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212616",
"marketing_category": "ANDA",
"nonproprietary_name": "Moxifloxacin Hydrochloride",
"start_marketing_date": "20210210",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code J01MA14.
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