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United States · US · US:16714-643_c11c970c-ffa6-4661-b515-708bae4eddd6
MOXIFLOXACIN
In shortageOrange BookUNIISPLATC J01MA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthStar Rx LLC
CountryUS (United States)
ATC codeJ01MA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1116714643011 BOTTLE in 1 CARTON (16714-643-01) / 3 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
A206242
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": "16714-643_c11c970c-ffa6-4661-b515-708bae4eddd6",
"productndc": "16714-643",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "206242",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT1",
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Oct 4, 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": "ANDA206242",
"marketing_category": "ANDA",
"nonproprietary_name": "MOXIFLOXACIN",
"start_marketing_date": "20171004",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code J01MA14.
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