FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
64980-211
11-digit product format
649800211
Labeler code
64980
Product ID
64980-211_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
15 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 CHLORIDE15 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
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-211-01Oxybutynin ChlorideExtended Release100 in 1 BOTTLETABLET, EXTENDED RELEASE10012
64980-211-05Oxybutynin ChlorideExtended Release500 in 1 BOTTLETABLET, EXTENDED RELEASE50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-211-01EA - Each64980-21165202438-6be2-401c-b98e-b7e32c9dea6b12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-211OXYBUTYNIN 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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-211-0164980021101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-211-01) 2016-09-270000-00-00NoNoCurrent
64980-211-0564980021105500 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-211-05) 2022-03-290000-00-00NoNoCurrent