Ofloxacin

Product NDC
50090-1744
11-digit product format
500901744
Labeler code
50090
Product ID
50090-1744_2c2b3d4c-0427-4618-8edd-435118c185bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA076622
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 formatDescriptionMarketing startSampleExclude flagStatus
50090-1744-0500901744001 BOTTLE, DROPPER in 1 CARTON (50090-1744-0) / 5 mL in 1 BOTTLE, DROPPER2015-03-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ofloxacin Ophthalmic Solution 0.3%A-S Medication Solutions2023-08-14HUMAN PRESCRIPTION DRUG LABEL5