Oxybutynin Chloride

Product NDC
67544-569
11-digit product format
675440569
Labeler code
67544
Product ID
67544-569_7c8f8413-4c41-4f54-9530-46f64782ced0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071655
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
OXYBUTYNIN CHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-569-53EA - Each67544-569acce3e17-af28-48ef-9166-a47bd81adb4a12017-12-14
67544-569-60EA - Each67544-569aca3d0bf-10f9-4f60-bf3a-13af5bc208d912017-12-14
67544-569-80EA - Each67544-569d2876c14-bd63-4a8f-b317-8bd9be72139f12017-12-14
67544-569-92EA - Each67544-569be96b926-bc5f-46f1-a8c7-834e78c2709312017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-569OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20171213_a16a5f0e-ae29-4b56-81a8-aa9398902a73.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-569-536754405695360 TABLET in 1 BOTTLE (67544-569-53) 60 tablet2015-08-030000-00-00NoNoCurrent
67544-569-606754405696090 TABLET in 1 BOTTLE (67544-569-60) 90 tablet2009-02-030000-00-00NoNoCurrent
67544-569-9267544056992270 TABLET in 1 BOTTLE (67544-569-92) 270 tablet2015-04-150000-00-00NoNoCurrent