FDA.reportPublic FDA data

Oxybutynin Chloride

Product NDC
50111-456
11-digit product format
501110456
Labeler code
50111
Product ID
50111-456_1811d8f0-3236-4dc7-a270-49e870188ff2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxybutynin Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA071655
Marketing category
ANDA
Marketing start
1990-09-30
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
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
50111-456-01Oxybutynin Chloride100 in 1 BOTTLETABLET10015
50111-456-02Oxybutynin Chloride500 in 1 BOTTLETABLET50015
50111-456-03Oxybutynin Chloride1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-456-01EA - Each50111-4564c8ca356-7fd1-4818-8ac7-906b87bca92d12012-07-24
50111-456-02EA - Each50111-4566f3c41c8-421e-4e28-94a8-3cbce353632c12012-07-24
50111-456-03EA - Each50111-4569b6b2ff6-8b9d-4078-ab17-cab3d192975d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYBUTYNIN CHLORIDE TABLET [PLIVA INC.]7
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYBUTYNIN CHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYBUTYNIN CHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50111-456OXYBUTYNIN CHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 3 package rows20241127_cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863664oxyBUTYnin chloride 5 MG Oral TabletPSNcb7aba8d-6913-4f57-8eb4-c6d6ff0b2a2915
863664oxybutynin chloride 5 MG Oral TabletSCDcb7aba8d-6913-4f57-8eb4-c6d6ff0b2a2915
863664oxyBUTYnin chloride 5 MG Oral TabletPSNe3f0c249-8085-4979-823a-820e233a284f5
863664oxyBUTYnin chloride 5 MG Oral TabletPSN246d2f79-8ab5-4023-9068-1451b695ac165
863664oxybutynin chloride 5 MG Oral TabletSCD246d2f79-8ab5-4023-9068-1451b695ac165
863664oxybutynin chloride 5 MG Oral TabletSCDe3f0c249-8085-4979-823a-820e233a284f5
863664oxyBUTYnin chloride 5 MG Oral TabletPSN19fba9db-69ff-4136-ad6b-04a33b6b67894
863664oxybutynin chloride 5 MG Oral TabletSCD19fba9db-69ff-4136-ad6b-04a33b6b67894
863636oxyBUTYnin chloride 5 MG 24HR Extended Release Oral TabletPSNb3d6d2a8-97c4-5bad-e053-2a95a90a155d3
863664oxyBUTYnin chloride 5 MG Oral TabletPSNb3d6d2a8-97c4-5bad-e053-2a95a90a155d3
86363624 HR oxybutynin chloride 5 MG Extended Release Oral TabletSCDb3d6d2a8-97c4-5bad-e053-2a95a90a155d3
863664oxybutynin chloride 5 MG Oral TabletSCDb3d6d2a8-97c4-5bad-e053-2a95a90a155d3
863636oxybutynin chloride 5 MG 24 HR Extended Release Oral TabletSYb3d6d2a8-97c4-5bad-e053-2a95a90a155d3
863664oxyBUTYnin chloride 5 MG Oral TabletPSNd2aa1b90-bea7-4a93-b2e7-22710548ff551
863664oxyBUTYnin chloride 5 MG Oral TabletPSN0fed0008-6569-3728-e054-00144ff88e881
863664oxybutynin chloride 5 MG Oral TabletSCD0fed0008-6569-3728-e054-00144ff88e881
863664oxybutynin chloride 5 MG Oral TabletSCDd2aa1b90-bea7-4a93-b2e7-22710548ff551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-456-0150111045601100 TABLET in 1 BOTTLE (50111-456-01) 100 tablet1990-09-300000-00-00NoNoCurrent
50111-456-0250111045602500 TABLET in 1 BOTTLE (50111-456-02) 500 tablet1990-09-300000-00-00NoNoCurrent
50111-456-03501110456031000 TABLET in 1 BOTTLE (50111-456-03) 1000 tablet1990-09-300000-00-00NoNoCurrent
50111-456-995011104569955586 TABLET in 1 CONTAINER (50111-456-99)55586 tablet23-SEP-19Current