OXYBUTYNIN CHLORIDE

Product NDC
0615-8492
11-digit product format
006158492
Labeler code
0615
Product ID
0615-8492_126741bf-877c-4f91-a0e0-a2378747e33b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYBUTYNIN CHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA212798
Marketing category
ANDA
Marketing start
2019-11-01
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
L9F3D9RENQOXYBUTYNIN CHLORIDE1508-65-2OXYBUTYNIN CHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8492-050061584920515 TABLET in 1 BLISTER PACK (0615-8492-05) 15 tablet2023-10-03NoNoHistorical
0615-8492-390061584923930 TABLET in 1 BLISTER PACK (0615-8492-39) 30 tablet2023-10-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oxybutynin Chloride Tablets, USPNCS HealthCare of KY, LLC dba Vangard Labs2023-10-04HUMAN PRESCRIPTION DRUG LABEL1