Oxybutynin Chloride

Product NDC
53808-0873
11-digit product format
538080873
Labeler code
53808
Product ID
53808-0873_7e123e63-4a3a-4a7a-8b45-e3d5ef102106
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA074625
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
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
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0873-22020-01-31C16284748780-19d75b9cf-f773-f424-e053-dadaa90a57ceOXYBUTYNIN CHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0873-2Oxybutynin Chloride60 in 1 BLISTER PACKTABLET601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0873OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_841eea91-2112-4940-868d-25ef085e8c76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN841eea91-2112-4940-868d-25ef085e8c761
863664oxybutynin chloride 5 MG Oral TabletSCD841eea91-2112-4940-868d-25ef085e8c761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0873-25380808730260 in 1 BLISTER PACKHistorical