FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
71610-394
11-digit product format
716100394
Labeler code
71610
Product ID
71610-394_7dee4b0d-3071-4962-82b6-0b0ff220f91a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxybutynin chloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210125
Marketing category
ANDA
Marketing start
2019-01-01
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
71610-394-53Oxybutynin Chloride60 in 1 BOTTLE, PLASTICTABLET603
71610-394-60Oxybutynin Chloride90 in 1 BOTTLE, PLASTICTABLET903
71610-394-80Oxybutynin Chloride180 in 1 BOTTLE, PLASTICTABLET1803
71610-394-92Oxybutynin Chloride270 in 1 BOTTLE, PLASTICTABLET2703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-394-53EA - Each71610-394968dfd06-c091-4223-b8c1-1b0046214e9612020-04-20
71610-394-60EA - Each71610-394eeae4da0-d6ea-4a42-a700-7e08eeb3246a12020-04-20
71610-394-92EA - Each71610-3942b2191aa-d6d3-4243-b985-5512afbb13c112020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-394OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 4 package rows20230105_1e1c1043-e4c5-4a06-9cc1-45d4397746f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN1e1c1043-e4c5-4a06-9cc1-45d4397746f43
863664oxybutynin chloride 5 MG Oral TabletSCD1e1c1043-e4c5-4a06-9cc1-45d4397746f43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-394-537161003945360 TABLET in 1 BOTTLE, PLASTIC (71610-394-53) 60 tablet2020-02-050000-00-00NoNoCurrent
71610-394-607161003946090 TABLET in 1 BOTTLE, PLASTIC (71610-394-60) 90 tablet2020-02-050000-00-00NoNoCurrent
71610-394-8071610039480180 TABLET in 1 BOTTLE, PLASTIC (71610-394-80) 180 tablet2022-12-300000-00-00NoNoCurrent
71610-394-9271610039492270 TABLET in 1 BOTTLE, PLASTIC (71610-394-92) 270 tablet2020-02-050000-00-00NoNoCurrent