FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
64980-210
11-digit product format
649800210
Labeler code
64980
Product ID
64980-210_6393f9a1-b51b-4baa-81f3-bb02d5e7dbc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA206121
Marketing category
ANDA
Marketing start
2016-09-27
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
Brand name suffix
Extended Release
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-210-01Oxybutynin ChlorideExtended Release100 in 1 BOTTLETABLET, EXTENDED RELEASE10012
64980-210-05Oxybutynin ChlorideExtended Release500 in 1 BOTTLETABLET, EXTENDED RELEASE50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-210-01EA - Each64980-2104048537b-4f03-4f87-8a18-c52894829d5c12016-12-07
64980-210-05EA - Each64980-21041191d39-8c4e-4de7-bcf0-ae622237734f12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-210OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]11Current NDC, Legacy NDC, 2 package rows20230707_ab431781-3183-4638-b656-f40a61f07940.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN169d6d58-8887-4bdd-95bd-873d1f049eaa102
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD169d6d58-8887-4bdd-95bd-873d1f049eaa102
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY169d6d58-8887-4bdd-95bd-873d1f049eaa102
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNe466d963-469a-4b1c-87f9-2e3e1e9bdf3d13
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDe466d963-469a-4b1c-87f9-2e3e1e9bdf3d13
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYe466d963-469a-4b1c-87f9-2e3e1e9bdf3d13
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNab431781-3183-4638-b656-f40a61f0794012
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSNab431781-3183-4638-b656-f40a61f0794012
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNab431781-3183-4638-b656-f40a61f0794012
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDab431781-3183-4638-b656-f40a61f0794012
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCDab431781-3183-4638-b656-f40a61f0794012
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDab431781-3183-4638-b656-f40a61f0794012
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYab431781-3183-4638-b656-f40a61f0794012
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSYab431781-3183-4638-b656-f40a61f0794012
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYab431781-3183-4638-b656-f40a61f0794012
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN3688227b-7655-40ca-b34b-073a39fd60f43
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD3688227b-7655-40ca-b34b-073a39fd60f43
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY3688227b-7655-40ca-b34b-073a39fd60f43
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN7d2332b4-9e48-4bb2-a2c3-75e16e1d455b1
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD7d2332b4-9e48-4bb2-a2c3-75e16e1d455b1
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY7d2332b4-9e48-4bb2-a2c3-75e16e1d455b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-210-0164980021001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-210-01) 2016-09-270000-00-00NoNoCurrent
64980-210-0564980021005500 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-210-05) 2022-03-290000-00-00NoNoCurrent