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 9 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.9042b7ad-15ed-0e81-e053-2a95a90afe282020-11-23WarningsExact identifier
unii: LMI26O6933
Post-VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.90bb15e5-3d9d-e2e2-e053-2995a90a85ac2020-11-23WarningsExact identifier
unii: LMI26O6933
Oxybutynin ChlorideOXYBUTYNIN CHLORIDELannett Company, Inc.615f3d95-197c-4fec-b81f-c26449c93c3b2020-02-21Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
H.M.D.ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOMZorex International8c53091a-904d-4756-93e4-17143c5b48e92018-12-21WarningsExact identifier
unii: LMI26O6933
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLCe985e201-2fb3-4781-9790-a1a3db1ae2a12017-10-20Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: LMI26O6933
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC58136f28-70c1-4cf2-bcd7-858c5609431a2016-06-15Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
b4a37481-c0d3-43dc-85f1-8cca6c6d8ba819fba9db-69ff-4136-ad6b-04a33b6b67892013-03-18Warnings, Adverse reactionsExact identifier
spl id: b4a37481-c0d3-43dc-85f1-8cca6c6d8ba8
spl set id: 19fba9db-69ff-4136-ad6b-04a33b6b6789

Reported adverse events (FAERS/openFDA)#

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