Ofloxacin

Product NDC
53002-1324
11-digit product format
530021324
Labeler code
53002
Product ID
53002-1324_97b40fc5-cba4-40f7-9ce1-b996cb583391
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076407
Marketing category
ANDA
Marketing start
2008-07-01
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53002-1324-1ML - Milliliter53002-13245e7377f8-5013-4dc6-a5ed-5cb58ce211eb12018-01-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1324-1530021324015 mL in 1 BOTTLE, DROPPER (53002-1324-1) 5 ml2017-09-010000-00-00NoNoCurrent