Moxifloxacin Hydrochloride

Product NDC
70518-4458
11-digit product format
705184458
Labeler code
70518
Product ID
70518-4458_3d584177-4ca7-3709-e063-6394a90abdaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202632
Marketing category
ANDA
Marketing start
2025-08-27
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
C53598599TMOXIFLOXACIN HYDROCHLORIDE186826-86-8MOXIFLOXACIN HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4458-0705184458007 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4458-0) 2025-08-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Moxifloxacin HydrochlorideREMEDYREPACK INC.2025-08-27HUMAN PRESCRIPTION DRUG LABEL1