FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
27241-156
11-digit product format
272410156
Labeler code
27241
Product ID
27241-156_7513158b-c4a4-4e1a-b329-55ee91c5569e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA211655
Marketing category
ANDA
Marketing start
2019-02-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBUTYNIN CHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ
Rxcui863619, 863628, 863636

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
3544f362-07fc-93b1-457b-1fba00be087aProduct name820230316
4daffbf2-44c8-ca46-d284-5db69e1e6ef4Product name820210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
982338c6-c45c-b6b4-1452-14b01fbdf98dProduct name220180801
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
054197ba-7ed3-0ddb-321e-dbb51c0fe9b6Product name220171212
3544f362-07fc-93b1-457b-1fba00be087aProduct name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8b00ae7e-01f2-f83c-632e-edfc23808364Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-156-04Oxybutynin Chloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
27241-156-08Oxybutynin Chloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-156-04EA - Each27241-156c5a366b7-8e6c-4db1-8416-46d95beec0cd12019-07-02
27241-156-08EA - Each27241-156eda5f7b8-42e2-48fb-874c-5c2316c196bc12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-156OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE [AJANTA PHARMA USA INC.]8Current NDC, Legacy NDC, 2 package rows20230530_95c2a144-ba0d-4011-ae0f-0e0ca876e8a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSN95c2a144-ba0d-4011-ae0f-0e0ca876e8a89
863628oxyBUTYnin chloride 15 MG 24HR Extended Release Oral TabletPSN95c2a144-ba0d-4011-ae0f-0e0ca876e8a89
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSN95c2a144-ba0d-4011-ae0f-0e0ca876e8a89
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCD95c2a144-ba0d-4011-ae0f-0e0ca876e8a89
86362824 HR oxybutynin chloride 15 MG Extended Release Oral TabletSCD95c2a144-ba0d-4011-ae0f-0e0ca876e8a89
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCD95c2a144-ba0d-4011-ae0f-0e0ca876e8a89
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSY95c2a144-ba0d-4011-ae0f-0e0ca876e8a89
863628oxybutynin chloride 15 MG 24 HR Extended Release Oral TabletSY95c2a144-ba0d-4011-ae0f-0e0ca876e8a89
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSY95c2a144-ba0d-4011-ae0f-0e0ca876e8a89
863619oxyBUTYnin chloride 10 MG 24HR Extended Release Oral TabletPSNa5965c8b-179d-4665-8a3b-324b693607ee5
86361924 HR oxybutynin chloride 10 MG Extended Release Oral TabletSCDa5965c8b-179d-4665-8a3b-324b693607ee5
863619oxybutynin chloride 10 MG 24 HR Extended Release Oral TabletSYa5965c8b-179d-4665-8a3b-324b693607ee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-156-0427241015604100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-156-04) 2019-02-280000-00-00NoNoCurrent
27241-156-0827241015608500 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-156-08) 2019-02-280000-00-00NoNoCurrent