ofloxacin

Product NDC
50090-7761
11-digit product format
500907761
Labeler code
50090
Product ID
50090-7761_bb143792-5a27-431d-840f-be1f517bdb0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA215886
Marketing category
ANDA
Marketing start
2023-12-01
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
50090-7761-0500907761005 mL in 1 BOTTLE, DROPPER (50090-7761-0) 5 ml2025-11-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ofloxacin Ophthalmic Solution USP, 0.3% sterileA-S Medication Solutions2025-11-12HUMAN PRESCRIPTION DRUG LABEL1