FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
64380-781
11-digit product format
643800781
Labeler code
64380
Product ID
64380-781_2994f946-dd30-4521-ab55-ee30ba1a6d5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA208165
Marketing category
ANDA
Marketing start
2024-12-20
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
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 CHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL9F3D9RENQ

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64380-781-032024-12-20C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-032024-12-20C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-052024-12-20C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-052024-12-20C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-062024-12-20C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-062024-12-20C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-072024-12-20C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-072024-12-20C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-082024-12-20C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-082024-12-20C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-032024-01-30C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-032024-01-30C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-052024-01-30C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-052024-01-30C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-062024-01-30C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-062024-01-30C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-072024-01-30C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-072024-01-30C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-082024-01-30C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP
64380-781-082024-01-30C16284748780-11030e365-2c5e-111a-e063-dadaa90a10e2OXYBUTYNIN CHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-781-03Oxybutynin Chloride60 in 1 BOTTLETABLET605
64380-781-05Oxybutynin Chloride90 in 1 BOTTLETABLET905
64380-781-06Oxybutynin Chloride100 in 1 BOTTLETABLET1005
64380-781-07Oxybutynin Chloride500 in 1 BOTTLETABLET5005
64380-781-08Oxybutynin Chloride1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-781-08EA - Each64380-7816ac252af-713f-4874-96fa-d891d74fcfbf12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-781OXYBUTYNIN CHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]4Current NDC, Legacy NDC, 5 package rows20241222_ac10c7b7-d0cb-4068-93e2-c0e51f15866e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN4574b227-9726-4798-bac2-83bfb9616f092
863664oxybutynin chloride 5 MG Oral TabletSCD4574b227-9726-4798-bac2-83bfb9616f092
863664oxyBUTYnin chloride 5 MG Oral TabletPSN3418ca19-feb0-9821-e063-6394a90ae8191
863664oxybutynin chloride 5 MG Oral TabletSCD3418ca19-feb0-9821-e063-6394a90ae8191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-781-036438007810360 TABLET in 1 BOTTLE (64380-781-03) 60 tablet2024-12-200000-00-00NoNoCurrent
64380-781-056438007810590 TABLET in 1 BOTTLE (64380-781-05) 90 tablet2024-12-200000-00-00NoNoCurrent
64380-781-0664380078106100 TABLET in 1 BOTTLE (64380-781-06) 100 tablet2024-12-200000-00-00NoNoCurrent
64380-781-0764380078107500 TABLET in 1 BOTTLE (64380-781-07) 500 tablet2024-12-200000-00-00NoNoCurrent
64380-781-08643800781081000 TABLET in 1 BOTTLE (64380-781-08) 1000 tablet2024-12-200000-00-00NoNoCurrent