Ofloxacin

Product NDC
68071-2454
11-digit product format
680712454
Labeler code
68071
Product ID
68071-2454_c548aea8-5869-1415-e053-2a95a90acd40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin Otic
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA211525
Marketing category
ANDA
Marketing start
2020-03-17
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2454-52023-01-30C16284748780-1f386c649-e56c-0266-e053-dadaa90a7c1ac548aea8-5868-1415-e053-2a95a90acd40

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2454OFLOXACIN (OFLOXACIN OTIC) SOLUTION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210622_c548aea8-5868-1415-e053-2a95a90acd40.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2454-5680712454051 BOTTLE, DROPPER in 1 CARTON (68071-2454-5) > 5 mL in 1 BOTTLE, DROPPER2021-06-210000-00-00NoNoCurrent