Oxybutynin Chloride

Product NDC
17856-0092
11-digit product format
178560092
Labeler code
17856
Product ID
17856-0092_964374bc-a367-4ee4-ad0e-d5178e41079b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
SYRUP
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA074868
Marketing category
ANDA
Marketing start
1997-02-12
Marketing end
0000-00-00
Substance
OXYBUTYNIN CHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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
17856-0092-12023-01-30C16284748780-1f386c64a-0e9a-0266-e053-dadaa90a7c1aOXYBUTYNIN CHLORIDE SYRUP, USP 5 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0092-1Oxybutynin Chloride5 mL in 1 CUPSYRUP54
17856-0092-1Oxybutynin Chloride72 in 1 CASESYRUP724

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0092OXYBUTYNIN CHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]4Legacy NDC, 2 package rows20210128_53a724ad-db62-4253-bfbf-2eab25726b89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863599oxyBUTYnin chloride 5 MG in 5 mL Oral SolutionPSN53a724ad-db62-4253-bfbf-2eab25726b894
863599oxybutynin chloride 1 MG/ML Oral SolutionSCD53a724ad-db62-4253-bfbf-2eab25726b894
863599oxybutynin chloride 5 MG per 5 ML Oral SolutionSY53a724ad-db62-4253-bfbf-2eab25726b894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0092-11785600920172 CUP in 1 CASE (17856-0092-1) > 5 mL in 1 CUP72 cup2021-01-270000-00-00NoNoCurrent