Ofloxacin

Product NDC
68788-8195
11-digit product format
687888195
Labeler code
68788
Product ID
68788-8195_bad243cc-10d2-4b50-99ff-44c78f37bab2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076407
Marketing category
ANDA
Marketing start
2022-05-26
Marketing end
0000-00-00
Substance
OFLOXACIN
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8195-5ML - Milliliter68788-81957a45b94c-e917-416f-9f93-bd7a6d7e2b5c12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8195OFLOXACIN SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS INC.]3Legacy NDC20240726_bad243cc-10d2-4b50-99ff-44c78f37bab2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8195-5687888195051 BOTTLE, DROPPER in 1 CARTON (68788-8195-5) > 5 mL in 1 BOTTLE, DROPPER2022-05-260000-00-00NoNoCurrent