Ofloxacin

Product NDC
70518-2037
11-digit product format
705182037
Labeler code
70518
Product ID
70518-2037_e39c7e79-253d-3e4b-e053-2a95a90ab3a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
REMEDYREPACK INC.
Application
ANDA078559
Marketing category
ANDA
Marketing start
2019-04-25
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2037OFLOXACIN SOLUTION [REMEDYREPACK INC.]11Legacy NDC20250306_69a92363-12fa-4e71-a03f-ba8acbcae1df.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2037-0705182037001 BOTTLE, PLASTIC in 1 CARTON (70518-2037-0) > 5 mL in 1 BOTTLE, PLASTIC2019-04-250000-00-00NoNoCurrent