ofloxacin

Product NDC
50090-6794
11-digit product format
500906794
Labeler code
50090
Product ID
50090-6794_911ade83-6dc1-4ef6-9f78-813bfdeba334
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
2022-12-07
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
50090-6794-0500906794001 BOTTLE, DROPPER in 1 CARTON (50090-6794-0) / 5 mL in 1 BOTTLE, DROPPER2023-11-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ofloxacin Ophthalmic Solution USP, 0.3% sterileA-S Medication Solutions2023-11-07HUMAN PRESCRIPTION DRUG LABEL1