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United States · US · US:68180-422_40262fef-9713-4538-b96b-c44b257d6a25
Moxifloxacin
In shortageOrange BookUNIISPLATC J01MA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01MA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168180422011 BOTTLE in 1 CARTON (68180-422-01) / 3 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
B8956S8609
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
RxCUI 1926505
Orange Book
A202867
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": "68180-422_40262fef-9713-4538-b96b-c44b257d6a25",
"productndc": "68180-422",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "202867",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT1",
"strength": "EQ 0.5% BASE",
"product_no": "001",
"approval_date": "Sep 4, 2014"
}
],
"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": "ANDA202867",
"marketing_category": "ANDA",
"nonproprietary_name": "Moxifloxacin",
"start_marketing_date": "20170701",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code J01MA14.
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