FDA.reportPublic FDA data

OXYBUTYNIN CHLORIDE

Product NDC
0093-5206
11-digit product format
000935206
Labeler code
0093
Product ID
0093-5206_b46c253f-c473-4b5f-a00b-cb775fae0c2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYBUTYNIN CHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TEVA Pharmaceuticals USA Inc
Application
ANDA076745
Marketing category
ANDA
Marketing start
2007-05-11
Marketing end
2020-05-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5206-01EA - Each0093-52060a2cc70c-8418-4d8c-b63e-1084637aa3b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
TALCINACTIVE INGREDIENT7SEV7J4R1UOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1001
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNb9090682-ea78-4f3e-9b07-c97d119d264b1001
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDb9090682-ea78-4f3e-9b07-c97d119d264b1001
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYb9090682-ea78-4f3e-9b07-c97d119d264b1001
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNa263f03a-af4b-45d8-9e71-9818042dd5c43
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDa263f03a-af4b-45d8-9e71-9818042dd5c43
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYa263f03a-af4b-45d8-9e71-9818042dd5c43
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNd6e59c6b-4599-435e-b077-4f949bc8ed0a1
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDd6e59c6b-4599-435e-b077-4f949bc8ed0a1
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYd6e59c6b-4599-435e-b077-4f949bc8ed0a1