FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
17856-0149
11-digit product format
178560149
Labeler code
17856
Product ID
17856-0149_35cef500-044f-9368-e063-6294a90a9ae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
SYRUP
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA074520
Marketing category
ANDA
Marketing start
1996-03-29
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
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863599

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
17856-0149-12025-03-18C16284748780-1d6a99b39-5383-a426-e053-dadaa90af4c2Oxybutynin Chloride Syrup USP
17856-0149-12022-01-28C16284748780-1d6a99b39-5383-a426-e053-dadaa90af4c2Oxybutynin Chloride Syrup USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0149-1Oxybutynin Chloride5 mL in 1 CUP, UNIT-DOSESYRUP53
17856-0149-1Oxybutynin Chloride72 in 1 BOX, UNIT-DOSESYRUP723

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0149OXYBUTYNIN CHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.]3Current NDC, Legacy NDC, 2 package rows20250524_fe4ed76b-0009-455f-be30-47e80fc1afdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863599oxyBUTYnin chloride 5 MG in 5 mL Oral SolutionPSNfe4ed76b-0009-455f-be30-47e80fc1afdf3
863599oxybutynin chloride 1 MG/ML Oral SolutionSCDfe4ed76b-0009-455f-be30-47e80fc1afdf3
863599oxybutynin chloride 5 MG per 5 ML Oral SolutionSYfe4ed76b-0009-455f-be30-47e80fc1afdf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0149-11785601490172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0149-1) / 5 mL in 1 CUP, UNIT-DOSE2020-03-050000-00-00NoNoCurrent