Ofloxacin

Product NDC
50090-0891
11-digit product format
500900891
Labeler code
50090
Product ID
50090-0891_18dee3f1-f0f5-4cb8-b212-290de77574f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0891-02023-02-07C16284748780-1f386c64a-3c51-0266-e053-dadaa90a7c1ac5ded8ed-9676-4cd7-8060-55d1eaf8cbe1
50090-0891-02023-01-30C16284748780-1f386c64a-3c51-0266-e053-dadaa90a7c1ac5ded8ed-9676-4cd7-8060-55d1eaf8cbe1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0891-0ML - Milliliter50090-0891ec0d15d9-bb15-4850-bb61-e6f3e19d11ce12018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0891-0500900891001 BOTTLE, DROPPER in 1 CARTON (50090-0891-0) > 5 mL in 1 BOTTLE, DROPPER2014-11-280000-00-00NoNoCurrent