FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
0904-6570
11-digit product format
009046570
Labeler code
0904
Product ID
0904-6570_4eb0d216-64dc-4192-88c1-39b134612e37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA204010
Marketing category
ANDA
Marketing start
2015-11-02
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
Rxcui863636

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
0904-6570-04Oxybutynin Chloride30 in 1 CARTONTABLET, EXTENDED RELEASE3010
0904-6570-04Oxybutynin Chloride1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE110
0904-6570-06Oxybutynin Chloride1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE110
0904-6570-06Oxybutynin Chloride50 in 1 CARTONTABLET, EXTENDED RELEASE5010
0904-6570-61Oxybutynin Chloride1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE110
0904-6570-61Oxybutynin Chloride100 in 1 CARTONTABLET, EXTENDED RELEASE10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6570-04EA - Each0904-6570c298e0ed-fb2d-4e65-b824-a790a6002dfb12018-08-13
0904-6570-06EA - Each0904-657049a949e8-c44c-49ec-99d2-648db55da05112016-11-08
0904-6570-61EA - Each0904-65705c6447fd-d461-4bcd-b3c9-e7b1359c724f12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6570OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]9Current NDC, Legacy NDC, 6 package rows20250206_7688cce8-797d-454c-95fb-52689741582e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN7688cce8-797d-454c-95fb-52689741582e10
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD7688cce8-797d-454c-95fb-52689741582e10
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY7688cce8-797d-454c-95fb-52689741582e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6570-040090465700430 BLISTER PACK in 1 CARTON (0904-6570-04) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK30 blister pack2015-11-020000-00-00NoNoCurrent
0904-6570-060090465700650 BLISTER PACK in 1 CARTON (0904-6570-06) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK50 blister pack2015-11-020000-00-00NoNoCurrent
0904-6570-6100904657061100 BLISTER PACK in 1 CARTON (0904-6570-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2015-11-020000-00-00NoNoCurrent