FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
0832-0038
11-digit product format
008320038
Labeler code
0832
Product ID
0832-0038_45af3420-b44f-39a1-e063-6394a90ad626
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA074625
Marketing category
ANDA
Marketing start
2011-11-07
Marketing end
2028-12-31
Substance
OXYBUTYNIN CHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxybutynin Chloride

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
0832-0038-00Oxybutynin Chloride100 in 1 BOTTLETABLET10017
0832-0038-01Oxybutynin Chloride100 in 1 CARTONTABLET10017
0832-0038-10Oxybutynin Chloride1000 in 1 BOTTLETABLET100017
0832-0038-50Oxybutynin Chloride500 in 1 BOTTLETABLET50017
0832-0038-89Oxybutynin Chloride1 in 1 BLISTER PACKTABLET117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0038-00EA - Each0832-0038f3763031-4e45-4646-a8ba-3d7de1546c3512012-07-24
0832-0038-01EA - Each0832-00381d2f3647-37a1-426a-948e-97432f95886d12018-06-11
0832-0038-10EA - Each0832-0038177cafb0-d308-4e31-89b9-4595cb6ea70e12012-07-24
0832-0038-50EA - Each0832-003845fb36e1-d85b-47fb-970b-be7fd4528abb12012-07-24
0832-0038-89EA - Each0832-0038ebc21517-3bb5-4b5e-a6ad-415af411acff12018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxybutynin ChlorideACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]8
OxybutyninACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]8
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]8
calcium stearateINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.]8
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0038OXYBUTYNIN CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC]15Current NDC, Legacy NDC, 5 package rows20230921_3ee6835a-7a7d-49a9-8460-2f1dd270ead3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSN3ee6835a-7a7d-49a9-8460-2f1dd270ead317
863664oxybutynin chloride 5 MG Oral TabletSCD3ee6835a-7a7d-49a9-8460-2f1dd270ead317
863664oxyBUTYnin chloride 5 MG Oral TabletPSN4eb9441b-27ba-1b8f-e054-00144ff88e883
863664oxybutynin chloride 5 MG Oral TabletSCD4eb9441b-27ba-1b8f-e054-00144ff88e883
863664oxyBUTYnin chloride 5 MG Oral TabletPSN58136f28-70c1-4cf2-bcd7-858c5609431a1
863664oxyBUTYnin chloride 5 MG Oral TabletPSN841eea91-2112-4940-868d-25ef085e8c761
863664oxyBUTYnin chloride 5 MG Oral TabletPSNc687e86b-1dc2-4f9c-a032-30f626f54d901
863664oxybutynin chloride 5 MG Oral TabletSCD58136f28-70c1-4cf2-bcd7-858c5609431a1
863664oxybutynin chloride 5 MG Oral TabletSCD841eea91-2112-4940-868d-25ef085e8c761
863664oxybutynin chloride 5 MG Oral TabletSCDc687e86b-1dc2-4f9c-a032-30f626f54d901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0038-0000832003800100 TABLET in 1 BOTTLE (0832-0038-00) 100 tablet2011-11-072028-07-31NoNoCurrent
0832-0038-0100832003801100 BLISTER PACK in 1 CARTON (0832-0038-01) / 1 TABLET in 1 BLISTER PACK (0832-0038-89) 100 blister pack2018-03-152026-07-31NoNoCurrent
0832-0038-10008320038101000 TABLET in 1 BOTTLE (0832-0038-10) 1000 tablet2011-11-072028-12-31NoNoCurrent
0832-0038-5000832003850500 TABLET in 1 BOTTLE (0832-0038-50) 500 tablet2011-11-072027-04-30NoNoCurrent
0832-0038-89008320038891 in 1 BLISTER PACKHistorical