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United States · US · US:72789-080_40319333-cf76-1664-e063-6294a90ae7e8
Moxifloxacin Hydrochloride Tablets, 400 mg
In shortageOrange BookUNIISPLATC J01MA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01MA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11727890801010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-080-10)
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": "72789-080_40319333-cf76-1664-e063-6294a90ae7e8",
"productndc": "72789-080",
"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": "20180721",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J01MA14.
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