FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
50090-6840
11-digit product format
500906840
Labeler code
50090
Product ID
50090-6840_79d91e25-4e04-4453-9001-82fbaecc525c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206121
Marketing category
ANDA
Marketing start
2016-09-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride
Brand name suffix
Extended Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863636

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
50090-6840-0Oxybutynin ChlorideExtended Release90 in 1 BOTTLETABLET, EXTENDED RELEASE905
50090-6840-1Oxybutynin ChlorideExtended Release30 in 1 BOTTLETABLET, EXTENDED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6840-0EA - Each50090-6840d7d462e1-2790-41d7-a4b7-37c7baec60ad12024-01-04
50090-6840-1EA - Each50090-6840184ad660-bce4-4366-8228-7d0f7a244d2512024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6840OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20241023_b9d0e5c8-3a71-40a0-a7d3-44bc043392fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNb9d0e5c8-3a71-40a0-a7d3-44bc043392fa5
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDb9d0e5c8-3a71-40a0-a7d3-44bc043392fa5
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYb9d0e5c8-3a71-40a0-a7d3-44bc043392fa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6840-05009068400090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6840-0) 2023-11-27NoNoHistorical
50090-6840-15009068400130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6840-1) 2023-11-27NoNoHistorical