FDA.reportPublic FDA data

oxybutynin chloride

Product NDC
16729-318
11-digit product format
167290318
Labeler code
16729
Product ID
16729-318_461437aa-cf86-2475-e063-6294a90afe5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA207138
Marketing category
ANDA
Marketing start
2016-12-20
Substance
OXYBUTYNIN CHLORIDE
Active strength
10 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

Additional Listing Data#

Finished product
Yes
Brand name base
oxybutynin chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863619, 863628, 863636

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-318-01oxybutynin chloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10013
16729-318-10oxybutynin chloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3013
16729-318-16oxybutynin chloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50013
16729-318-17oxybutynin chloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-318-01EA - Each16729-318b1666c80-3280-4790-9431-dd6483f9b18612017-03-06
16729-318-16EA - Each16729-318e672fe5e-5a13-4c5b-8a4b-881945dea14512017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-318OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]12Current NDC, Legacy NDC, 4 package rows20240328_61496a1e-17bf-4f45-a20c-5bb98fe545ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNa1f8be75-2eb9-4eef-8fb4-144ef2bf7ae117
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDa1f8be75-2eb9-4eef-8fb4-144ef2bf7ae117
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYa1f8be75-2eb9-4eef-8fb4-144ef2bf7ae117
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN61496a1e-17bf-4f45-a20c-5bb98fe545ee13
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSN61496a1e-17bf-4f45-a20c-5bb98fe545ee13
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN61496a1e-17bf-4f45-a20c-5bb98fe545ee13
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD61496a1e-17bf-4f45-a20c-5bb98fe545ee13
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCD61496a1e-17bf-4f45-a20c-5bb98fe545ee13
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD61496a1e-17bf-4f45-a20c-5bb98fe545ee13
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY61496a1e-17bf-4f45-a20c-5bb98fe545ee13
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSY61496a1e-17bf-4f45-a20c-5bb98fe545ee13
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY61496a1e-17bf-4f45-a20c-5bb98fe545ee13
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN8f147f73-cfc6-40a3-b1a3-e4cab186852310
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD8f147f73-cfc6-40a3-b1a3-e4cab186852310
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY8f147f73-cfc6-40a3-b1a3-e4cab186852310
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNada3be87-2cdd-75f7-e053-2995a90aa95b2
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDada3be87-2cdd-75f7-e053-2995a90aa95b2
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYada3be87-2cdd-75f7-e053-2995a90aa95b2
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN88f08450-559e-4038-aad1-051e4ab283cf1
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD88f08450-559e-4038-aad1-051e4ab283cf1
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY88f08450-559e-4038-aad1-051e4ab283cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-318-0116729031801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-01) 2016-12-200000-00-00NoNoCurrent
16729-318-101672903181030 in 1 BOTTLEHistorical
16729-318-1616729031816500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-318-16) 2017-04-170000-00-00NoNoCurrent
16729-318-17167290318171000 in 1 BOTTLEHistorical