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United States · US · US:70518-4312_402db01e-845f-d529-e063-6394a90a16f9
Moxifloxacin Hydrochloride Tablets, 400 mg
In shortageOrange BookUNIISPLATC J01MA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ01MA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170518431207 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4312-0)
Annotations
UNII (FDA Substance ID)
B8956S8609
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
RxCUI 1926505
Orange Book
A208682
AB
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": "ORAL",
"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": "70518-4312_402db01e-845f-d529-e063-6394a90a16f9",
"productndc": "70518-4312",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208682",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 400MG BASE",
"product_no": "001",
"approval_date": "Sep 22, 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 Hydrochloride Tablets, 400 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208682",
"marketing_category": "ANDA",
"nonproprietary_name": "Moxifloxacin Hydrochloride Tablets, 400 mg",
"start_marketing_date": "20250318",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J01MA14.
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