Oxybutynin Chloride

Product NDC
0615-8428
11-digit product format
006158428
Labeler code
0615
Product ID
0615-8428_06081cba-ac29-4db7-9504-463425b03ae0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA075079
Marketing category
ANDA
Marketing start
2022-04-04
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8428-390061584283930 TABLET in 1 BLISTER PACK (0615-8428-39) 30 tablet2022-07-150000-00-00NoNoCurrent