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United States · US · US:72205-001_79a88ea4-ddf4-4ee9-acc2-91047ce636d5
Moxifloxacin Hydrochloride Tablets, 400 mg
In shortageOrange BookUNIISPLATC J01MA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeJ01MA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117220500105500 TABLET, FILM COATED in 1 BOTTLE (72205-001-05)
- ndc11722050013030 TABLET, FILM COATED in 1 BOTTLE (72205-001-30)
- ndc11722050013150 BLISTER PACK in 1 CARTON (72205-001-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-001-11)
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": "72205-001_79a88ea4-ddf4-4ee9-acc2-91047ce636d5",
"productndc": "72205-001",
"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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