Oxybutynin Chloride

Product NDC
66267-642
11-digit product format
662670642
Labeler code
66267
Product ID
66267-642_1fa711ca-cee8-fae5-e063-6294a90aa5d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209823
Marketing category
ANDA
Marketing start
2017-11-15
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
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 CHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863664

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
66267-642-302024-08-14C16284748780-1f386c64a-1c2f-0266-e053-dadaa90a7c1aOxybutynin Chloride Tablets, USP 5 mg Rx only
66267-642-302023-01-30C16284748780-1f386c64a-1c2f-0266-e053-dadaa90a7c1aOxybutynin Chloride Tablets, USP 5 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-642-30Oxybutynin Chloride30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-642-30EA - Each66267-642ba43ac97-10db-4086-b212-c22efb2caee412019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-642OXYBUTYNIN CHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240815_8e830697-a6d3-13ed-e053-2995a90acb11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN8e830697-a6d3-13ed-e053-2995a90acb113
863664oxybutynin chloride 5 MG Oral TabletSCD8e830697-a6d3-13ed-e053-2995a90acb113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-642-306626706423030 TABLET in 1 BOTTLE (66267-642-30) 30 tablet2019-07-250000-00-00NoNoCurrent