FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
43353-769
11-digit product format
433530769
Labeler code
43353
Product ID
43353-769_36b19b28-8577-4be5-bab3-b8f32b9f6a33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, Inc.
Application
ANDA078503
Marketing category
ANDA
Marketing start
2009-03-01
Marketing end
0000-00-00
Substance
OXYBUTYNIN CHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-769-412019-11-13C16284748780-197449f38-b960-f6ea-e053-dbdaa90aa703Oxybutynin Chloride Extended-Release Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-769-41Oxybutynin Chloride1600 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE16002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-769-41EA - Each43353-7695789ad00-3e0c-4489-81d1-1a01eae59fc212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxybutynin ChlorideACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
OxybutyninACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
anhydrous dextroseINACTIVE INGREDIENT5SL0G7R0OKOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
cellulose acetateINACTIVE INGREDIENT3J2P07GVB6OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
mannitolINACTIVE INGREDIENT3OWL53L36AOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
tartaric acidINACTIVE INGREDIENTW4888I119HOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
triacetinINACTIVE INGREDIENTXHX3C3X673OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-769OXYBUTYNIN CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2Legacy NDC, 1 package rows20120327_3272aaff-8d07-4be5-987f-ef3c5079a133.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN3272aaff-8d07-4be5-987f-ef3c5079a1332
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD3272aaff-8d07-4be5-987f-ef3c5079a1332
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY3272aaff-8d07-4be5-987f-ef3c5079a1332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-769-41433530769411600 in 1 BOTTLE, PLASTICHistorical