FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
71610-277
11-digit product format
716100277
Labeler code
71610
Product ID
71610-277_b28dba2b-b19b-469e-98d8-54e87e3800e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA209823
Marketing category
ANDA
Marketing start
2017-10-23
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
71610-277-30Oxybutynin Chloride30 in 1 BOTTLETABLET302
71610-277-53Oxybutynin Chloride60 in 1 BOTTLETABLET602
71610-277-60Oxybutynin Chloride90 in 1 BOTTLETABLET902
71610-277-80Oxybutynin Chloride180 in 1 BOTTLETABLET1802
71610-277-92Oxybutynin Chloride270 in 1 BOTTLETABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-277-30EA - Each71610-277bbeea2ab-e614-4063-972c-6fdea3a3b4df12023-07-06
71610-277-53EA - Each71610-2776fc0a6e0-7985-471d-a7f8-0c2337e347bf12019-07-02
71610-277-60EA - Each71610-277e494e17d-cc4f-43a4-80e2-3eef13849a6212019-07-02
71610-277-80EA - Each71610-277109811a7-f4fc-42c9-bbea-2b5ece1a304f12019-07-02
71610-277-92EA - Each71610-277174755aa-35bf-458a-88c9-53446d43120012019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-277OXYBUTYNIN CHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 5 package rows20230602_d2bb6927-5fbf-49ca-a891-d701bff1c812.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSNd2bb6927-5fbf-49ca-a891-d701bff1c8122
863664oxybutynin chloride 5 MG Oral TabletSCDd2bb6927-5fbf-49ca-a891-d701bff1c8122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-277-307161002773030 TABLET in 1 BOTTLE (71610-277-30) 30 tablet2023-05-31NoNoHistorical
71610-277-537161002775360 TABLET in 1 BOTTLE (71610-277-53) 60 tablet2019-05-130000-00-00NoNoCurrent
71610-277-607161002776090 TABLET in 1 BOTTLE (71610-277-60) 90 tablet2019-05-130000-00-00NoNoCurrent
71610-277-8071610027780180 TABLET in 1 BOTTLE (71610-277-80) 180 tablet2019-05-130000-00-00NoNoCurrent
71610-277-9271610027792270 TABLET in 1 BOTTLE (71610-277-92) 270 tablet2019-05-130000-00-00NoNoCurrent