MOXIFLOXACIN

Product NDC
72189-334
11-digit product format
721890334
Labeler code
72189
Product ID
72189-334_2c3d95a4-32d2-ef3b-e063-6294a90ac144
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOXIFLOXACIN
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Direct Rx
Application
ANDA202916
Marketing category
ANDA
Marketing start
2022-03-08
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
5 mg/mL
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
U188XYD42PMOXIFLOXACIN151096-09-2MOXIFLOXACIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-334-05721890334053 mL in 1 BOTTLE (72189-334-05) 3 ml2022-03-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MOXIFLOXACIN OPTH SOLN 0.5% 3MLDirect Rx2025-01-21HUMAN PRESCRIPTION DRUG LABEL2