FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
43063-790
11-digit product format
430630790
Labeler code
43063
Product ID
43063-790_419e3f00-a475-03d5-e063-6394a90a5f89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078503
Marketing category
ANDA
Marketing start
2009-03-01
Substance
OXYBUTYNIN CHLORIDE
Active strength
10 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
Brand name suffix
Extended Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863619

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-790-90Oxybutynin ChlorideExtended Release90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9044

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-790-90EA - Each43063-790209a6781-c4dd-4e72-9914-4ac9953df97212017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-790OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]43Current NDC, Legacy NDC, 1 package rows20241017_b5653b7e-1e3b-4da3-b3a2-33318f448c67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNb5653b7e-1e3b-4da3-b3a2-33318f448c6744
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDb5653b7e-1e3b-4da3-b3a2-33318f448c6744
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYb5653b7e-1e3b-4da3-b3a2-33318f448c6744

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-790-904306307909090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-790-90) 2017-09-210000-00-00NoNoCurrent