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United States · US · US:80425-0239_2a9aa671-d0a2-2254-e063-6294a90a9f79
Moxifloxacin
In shortageOrange BookUNIISPLATC J01MA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeJ01MA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1180425023911 BOTTLE, DROPPER in 1 CARTON (80425-0239-1) / 3 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
B8956S8609
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
RxCUI 1926505
Orange Book
A090080
AT1
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Moxifloxacin Injection
Raw payload (JSON)
{
"unii": {
"unii": "B8956S8609",
"rxcui": "1926505",
"inchikey": "SKZIMSDWAIZNDD-WJMOHVQJSA-N",
"display_name": "MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE",
"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": "80425-0239_2a9aa671-d0a2-2254-e063-6294a90a9f79",
"productndc": "80425-0239",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "090080",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT1",
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Jun 30, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE",
"shortage_reason": "Moxifloxacin Injection",
"shortage_status": "current",
"proprietary_name": "Moxifloxacin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA090080",
"marketing_category": "ANDA",
"nonproprietary_name": "Moxifloxacin",
"start_marketing_date": "20230111",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code J01MA14.
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