Oxybutynin Chloride

Product NDC
43063-851
11-digit product format
430630851
Labeler code
43063
Product ID
43063-851_2fc3d8ae-3605-f8df-e063-6294a90ab12f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA209335
Marketing category
ANDA
Marketing start
2017-12-22
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
43063-851-01Oxybutynin Chloride100 in 1 BOTTLE, PLASTICTABLET10015
43063-851-60Oxybutynin Chloride60 in 1 BOTTLE, PLASTICTABLET6015
43063-851-90Oxybutynin Chloride90 in 1 BOTTLE, PLASTICTABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-851-01EA - Each43063-8519f74b832-3802-4b9f-8690-ea8f36f177e812019-04-11
43063-851-60EA - Each43063-851f397a88c-5e62-4454-9ecc-f7d9667b1df312018-07-03
43063-851-90EA - Each43063-851341f7d3b-6810-448b-936a-e899d1b0591a12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-851OXYBUTYNIN CHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 3 package rows20250309_0c021aad-97a3-4404-a11e-cdd2ec731c6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN0c021aad-97a3-4404-a11e-cdd2ec731c6b15
863664oxybutynin chloride 5 MG Oral TabletSCD0c021aad-97a3-4404-a11e-cdd2ec731c6b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-851-0143063085101100 TABLET in 1 BOTTLE, PLASTIC (43063-851-01) 100 tablet2019-03-210000-00-00NoNoCurrent
43063-851-604306308516060 TABLET in 1 BOTTLE, PLASTIC (43063-851-60) 60 tablet2018-06-110000-00-00NoNoCurrent
43063-851-904306308519090 TABLET in 1 BOTTLE, PLASTIC (43063-851-90) 90 tablet2018-06-110000-00-00NoNoCurrent