FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
62135-520
11-digit product format
621350520
Labeler code
62135
Product ID
62135-520_2f102c1a-f5e5-43a2-e063-6294a90a0a91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA075039
Marketing category
ANDA
Marketing start
1999-01-29
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-520-05Oxybutynin Chloride5 mL in 1 CUPSOLUTION52
62135-520-24Oxybutynin Chloride2 in 1 BOXSOLUTION22
62135-520-24Oxybutynin Chloride10 in 1 TRAYSOLUTION102
62135-520-47Oxybutynin Chloride473 mL in 1 BOTTLESOLUTION4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-520OXYBUTYNIN CHLORIDE SOLUTION [CHARTWELL RX, LLC]2Current NDC, Legacy NDC, 4 package rows20250228_d02e411b-2f34-4d08-a92a-9762cab47269.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863599oxyBUTYnin chloride 5 MG in 5 mL Oral SolutionPSNd02e411b-2f34-4d08-a92a-9762cab472692
863599oxybutynin chloride 1 MG/ML Oral SolutionSCDd02e411b-2f34-4d08-a92a-9762cab472692
863599oxybutynin chloride 5 MG per 5 ML Oral SolutionSYd02e411b-2f34-4d08-a92a-9762cab472692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-520-05621350520055 mL in 1 CUP5 mlHistorical
62135-520-24621350520242 TRAY in 1 BOX (62135-520-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-520-05) 2 tray2025-02-26NoNoCurrent
62135-520-4762135052047473 mL in 1 BOTTLE (62135-520-47) 473 ml2022-12-190000-00-00NoNoCurrent