Ofloxacin Otic

Product NDC
71335-2822
11-digit product format
713352822
Labeler code
71335
Product ID
71335-2822_ca67210a-78ed-4295-b38b-9fa0cdf85664
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Bryant Ranch Prepack
Application
ANDA076527
Marketing category
ANDA
Marketing start
2004-05-14
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
A4P49JAZ9HOFLOXACIN82419-36-1OFLOXACIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2822-1713352822015 mL in 1 BOTTLE, DROPPER (71335-2822-1) 5 ml2025-10-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ofloxacin Otic Solution 0.3%Bryant Ranch Prepack2025-10-30HUMAN PRESCRIPTION DRUG LABEL100