FDA.reportPublic FDA data

OXYBUTYNIN CHLORIDE

Product NDC
69315-182
11-digit product format
693150182
Labeler code
69315
Product ID
69315-182_da4b3e8b-09d1-4ef3-a24a-ef078f13bd92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYBUTYNIN CHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA212798
Marketing category
ANDA
Marketing start
2019-11-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-182-01OXYBUTYNIN CHLORIDE100 in 1 BOTTLETABLET1008
69315-182-05OXYBUTYNIN CHLORIDE500 in 1 BOTTLETABLET5008
69315-182-10OXYBUTYNIN CHLORIDE1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-182-01EA - Each69315-182e2b1ca77-ddc2-47cc-8804-52e0ee76fa9012021-06-02
69315-182-05EA - Each69315-182d238a9ef-fc0b-48dd-988f-7a58cec9764512021-06-02
69315-182-10EA - Each69315-18212d2538c-22ba-41bb-9e4a-f4196b059a9d12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-182OXYBUTYNIN CHLORIDE TABLET [LEADING PHARMA, LLC]8Current NDC, Legacy NDC, 3 package rows20220215_b73b8338-8045-448f-87a6-3d289227d00e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSNb73b8338-8045-448f-87a6-3d289227d00e8
863664oxybutynin chloride 5 MG Oral TabletSCDb73b8338-8045-448f-87a6-3d289227d00e8
863664oxyBUTYnin chloride 5 MG Oral TabletPSN83522acd-0ecc-46ac-a018-a3205ba096ff3
863664oxybutynin chloride 5 MG Oral TabletSCD83522acd-0ecc-46ac-a018-a3205ba096ff3
863664oxyBUTYnin chloride 5 MG Oral TabletPSNfc4cfbe6-a940-41c0-e053-6294a90adb142
863664oxybutynin chloride 5 MG Oral TabletSCDfc4cfbe6-a940-41c0-e053-6294a90adb142
863664oxyBUTYnin chloride 5 MG Oral TabletPSN5b72d34e-ae57-4459-ba2c-3bae8a69c5c11
863664oxybutynin chloride 5 MG Oral TabletSCD5b72d34e-ae57-4459-ba2c-3bae8a69c5c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-182-0169315018201100 TABLET in 1 BOTTLE (69315-182-01) 100 tablet2019-11-010000-00-00NoNoCurrent
69315-182-0569315018205500 TABLET in 1 BOTTLE (69315-182-05) 500 tablet2019-11-010000-00-00NoNoCurrent
69315-182-10693150182101000 TABLET in 1 BOTTLE (69315-182-10) 1000 tablet2019-11-010000-00-00NoNoCurrent