Oxybutynin Chloride

Product NDC
0904-7027
11-digit product format
009047027
Labeler code
0904
Product ID
0904-7027_dfc72462-93cb-4e29-bd55-dbd31a4b5b84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA209823
Marketing category
ANDA
Marketing start
2017-11-15
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
0904-7027-61Oxybutynin Chloride100 in 1 CARTONTABLET1004
0904-7027-61Oxybutynin Chloride1 in 1 BLISTER PACKTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7027-61EA - Each0904-7027060db9ec-0918-49a2-9e7a-96588094a60c12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7027OXYBUTYNIN CHLORIDE TABLET [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20250101_7769ad3d-6228-4b2d-8f44-4efe990d3fad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN7769ad3d-6228-4b2d-8f44-4efe990d3fad4
863664oxybutynin chloride 5 MG Oral TabletSCD7769ad3d-6228-4b2d-8f44-4efe990d3fad4
863664oxyBUTYnin chloride 5 MG Oral TabletPSN8455b543-81ce-4522-ae9b-8396f944945c3
863664oxybutynin chloride 5 MG Oral TabletSCD8455b543-81ce-4522-ae9b-8396f944945c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7027-6100904702761100 BLISTER PACK in 1 CARTON (0904-7027-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2017-11-150000-00-00NoNoCurrent