MOXIFLOXACIN

Product NDC
82804-055
11-digit product format
828040055
Labeler code
82804
Product ID
82804-055_c38e051f-5765-4066-9953-2d0832481b1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOXIFLOXACIN
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Proficient Rx LP
Application
ANDA206242
Marketing category
ANDA
Marketing start
2017-10-04
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
82804-055-03828040055031 BOTTLE in 1 CARTON (82804-055-03) / 3 mL in 1 BOTTLE1 bottle2024-01-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MOXIFLOXACINProficient Rx LP2024-01-01HUMAN PRESCRIPTION DRUG LABEL1