FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
70518-2640
11-digit product format
705182640
Labeler code
70518
Product ID
70518-2640_4a7c6cdc-4b20-7a2a-e063-6294a90aaea2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209335
Marketing category
ANDA
Marketing start
2020-03-26
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2640-02022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-12022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-22022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-32022-01-31C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-02022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-12022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-22022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only
70518-2640-32022-01-28C16284748780-1d6a99b39-b1a4-a426-e053-dadaa90af4c2OXYBUTYNIN CHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2640-0Oxybutynin Chloride30 in 1 BLISTER PACKTABLET309
70518-2640-1Oxybutynin Chloride60 in 1 BOTTLE, PLASTICTABLET609
70518-2640-2Oxybutynin Chloride90 in 1 BOTTLE, PLASTICTABLET909
70518-2640-3Oxybutynin Chloride180 in 1 BOTTLE, PLASTICTABLET1809
70518-2640-4Oxybutynin Chloride30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2640OXYBUTYNIN CHLORIDE TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 5 package rows20250104_1a08a16a-f16d-4ef1-95bb-6943bcae0737.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN1a08a16a-f16d-4ef1-95bb-6943bcae07379
863664oxybutynin chloride 5 MG Oral TabletSCD1a08a16a-f16d-4ef1-95bb-6943bcae07379

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2640-07051826400030 TABLET in 1 BLISTER PACK (70518-2640-0) 30 tablet2020-03-260000-00-00NoNoCurrent
70518-2640-17051826400160 TABLET in 1 BOTTLE, PLASTIC (70518-2640-1) 60 tablet2020-03-260000-00-00NoNoCurrent
70518-2640-27051826400290 TABLET in 1 BOTTLE, PLASTIC (70518-2640-2) 90 tablet2020-06-110000-00-00NoNoCurrent
70518-2640-370518264003180 TABLET in 1 BOTTLE, PLASTIC (70518-2640-3) 180 tablet2020-06-110000-00-00NoNoCurrent
70518-2640-47051826400430 in 1 BLISTER PACKHistorical