FDA.reportPublic FDA data

NDC 54868-2157-4 - Oxybutynin Chloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
54868-2157
Requested NDC
54868-2157-4
Package NDCs from labels
54868-2157-1, 54868-2157-2, 54868-2157-3, 54868-2157-5, 54868-2157-4
Manufacturer
Physicians Total Care, Inc.
Effective date
2013-03-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OXYBUTYNIN CHLORIDE Tablets USPPhysicians Total Care, Inc.2013-03-18HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
54868-2157-1OXYBUTYNIN CHLORIDE Tablets USP
54868-2157-2OXYBUTYNIN CHLORIDE Tablets USP
54868-2157-3OXYBUTYNIN CHLORIDE Tablets USP
54868-2157-5OXYBUTYNIN CHLORIDE Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-2157-1Oxybutynin Chloride30 in 1 BOTTLETABLET304
54868-2157-2Oxybutynin Chloride100 in 1 BOTTLETABLET1004
54868-2157-3Oxybutynin Chloride60 in 1 BOTTLETABLET604
54868-2157-5Oxybutynin Chloride90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-2157OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]44 package rows20130319_19fba9db-69ff-4136-ad6b-04a33b6b6789.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-2157-1EA - Each54868-215702e0df2a-0dfd-439c-8c2b-61e8905739dc12012-07-24
54868-2157-2EA - Each54868-21570cab6182-6d98-4bb1-bbeb-384c0c0f42fa12012-07-24
54868-2157-3EA - Each54868-2157d5c96fe3-d79c-4f47-ab7b-ffe7bca50b5412012-07-24
54868-2157-4EA - Each54868-21577b0498cd-33dd-4e1e-a7fe-0182b79207c412012-07-24
54868-2157-5EA - Each54868-2157f88749e7-738e-4474-9bd8-58edb87ae4d912015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin ChlorideOXYBUTYNIN CHLORIDENuCare Pharmaceuticals,Inc.8e830697-a6d3-13ed-e053-2995a90acb112024-08-14Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
oxybutyninOXYBUTYNINNCS HealthCare of KY, LLC dba Vangard Labsed10f0c9-23d6-4ded-b17f-ed474632a9652024-08-12Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEBryant Ranch Prepackf26e590d-956e-493b-a6ac-6056aeeaf4112024-08-09Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Mind Detox and DrainageALUMINA, BARYTA CARBONICA, CARBONEUM SULPHURATUM, CEREBRUM SUIS, CONIUM MACULATUM, HELLEBORUS NIGER, LECITHIN, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PICRICUM ACIDUM, PLATINUM METALLICUM, SILICEA, STRAMONIUM, SULPHURICUM ACIDUM, ZINCUM PHOSPHORATUMDeseret Biologicals, Inc.1ac1e955-a374-4cac-b997-51c6aef8d35d2024-08-01WarningsExact identifier
unii: LMI26O6933
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDERISING PHARMA HOLDINGS, INC.f8ed80f2-6c3d-4d7f-b761-c2447973c1f92024-07-03Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
MetalsALUMINA, AURUM METALLICUM, CARBO VEGETABILIS, CAUSTICUM, CYSTEINUM, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, NITRICUM ACIDUM, NUX VOMICA, PHYTOLACCA DECANDRA, PLATINUM METALLICUM, STANNUM METALLICUM, STILLINGIA SYLVATICA, TELLURIUM METALLICUM, X-RAYLiddell Laboratories, Inc.daa89e0d-1dd8-45eb-9f9b-0029fdcfecee2024-07-01WarningsExact identifier
unii: LMI26O6933
oxybutynin chlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions7593becc-250f-4d25-8401-a9f72f3f5ad42024-06-03Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions8f147f73-cfc6-40a3-b1a3-e4cab18685232024-06-03Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions39a2d144-0c10-4aec-9fa4-0adc24b332eb2024-06-03Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
ALUMINAALUMINARxhomeo Private Limited d.b.a. Rxhomeo, Inc1996ed79-ffb8-709a-e063-6394a90a99382024-05-29WarningsExact identifier
unii: LMI26O6933
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEBryant Ranch Prepack169d6d58-8887-4bdd-95bd-873d1f049eaa2024-05-24Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Neurotransmitter ProAETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), OXYTOCIN, SEROTONIN (HYDROCHLORIDE)Energique, Inc.a80e5e2d-4c53-4b18-b89b-a7790073b7ed2024-05-06WarningsExact identifier
unii: LMI26O6933
Neurotransmitter ProAETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), SEROTONIN (HYDROCHLORIDE), OXYTOCINEnergique, Inc.b433c635-e38b-4b3a-89cb-4a72a386ad842024-05-06WarningsExact identifier
unii: LMI26O6933
MotivationDIOSCOREA VILLOSA, LECITHIN, SEPIA, VIOLA ODORATA, ADRENALINUM, LITHIUM CARBONICUM, THYROIDINUM (BOVINE), PLACENTA TOTALIS SUIS, GUAIACUM, SOLANUM TUBEROSUM, ANTIMONIUM CRUDUM, AURUM SULPHURATUM, BARYTA CARBONICA, CHININUM SULPHURICUM, CONIUM MACULATUM, GRAPHITES, LILIUM TIGRINUM, RHUS VENENATA, SELENIUM METALLICUM, ALUMINADeseret Biologicals, Inc.c2bb0fb2-7ffa-4d16-8fff-b4c3dde966f42024-04-01WarningsExact identifier
unii: LMI26O6933
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEProficient Rx LP7d2332b4-9e48-4bb2-a2c3-75e16e1d455b2024-04-01Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
ElevateLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)Deseret Biologicals, Inc.5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b2024-03-11WarningsExact identifier
unii: LMI26O6933
Lung Large Intestine Meridian OpenerALOE, ALUMINA, APIS MELLIFICA, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA (ALBA), CARBO VEGETABILIS, CHAMOMILLA, KALI BICHROMICUM, PHOSPHORUS, PLUMBUM METALLICUM, PYROGENIUM, SULPHURDeseret Biologicals, Inca5c17770-e1c0-48e7-8947-c0434c22cdab2024-02-21WarningsExact identifier
unii: LMI26O6933
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEBryant Ranch Prepack2f898b29-46cf-4427-bb64-8c30532222f52024-01-18Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions5e3b454b-6d3c-418b-8ac2-b0e17f018bbf2023-12-27Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutionsafc6a3aa-e43d-4f10-bdbd-570a149bf9db2023-12-27Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.