FDA.reportPublic FDA data

NDC 70771-1087-2 - oxybutynin

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
70771-1087
Requested NDC
70771-1087-2
Package NDCs from labels
70771-1087-6, 70771-1087-1, 70771-1087-9, 70771-1087-5, 70771-1087-3, 70771-1087-2, 70771-1087-4
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-12-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
oxybutynin - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-12-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1087-1oxybutynin100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008
70771-1087-2oxybutynin10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE108
70771-1087-3oxybutynin30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE308
70771-1087-4oxybutynin10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE108
70771-1087-5oxybutynin500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5008
70771-1087-6oxybutynin60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE608
70771-1087-9oxybutynin90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1087OXYBUTYNIN TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 7 package rows20241206_f405a774-bd91-4513-b7c7-c44f0596d988.zip

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 5 of 9 · 180 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAvKARE94471401-a516-0fe7-ec9c-447dd2bee9722025-12-16Warnings, Adverse reactionsExact identifier
rxcui: 863636
rxcui: 863619
rxcui: 863628
unii: L9F3D9RENQ
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: 3NXW29V3WO
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEUpsher-Smith Laboratories, LLC3ee6835a-7a7d-49a9-8460-2f1dd270ead32025-12-11Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAjanta Pharma USA Inc.95c2a144-ba0d-4011-ae0f-0e0ca876e8a82025-11-30Warnings, Adverse reactionsExact identifier
rxcui: 863636
rxcui: 863619
rxcui: 863628
unii: L9F3D9RENQ
OUHOE Biotin With Hydrolyzed CollagenGLYCERINShantou Ouhoe Technology Co., Ltd.43138915-5fe1-6e32-e063-6294a90abefa2025-11-27WarningsExact identifier
unii: ZF94AP8MEY
HOUKEA Pure Magnesium OilGLYCERINGuangzhou Houkea Biotechnology Co., Ltd.33fc279b-3b15-973d-e063-6394a90aad3e2025-11-27WarningsExact identifier
unii: ZF94AP8MEY
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEA-S Medication Solutions44990ed6-b8e7-40f5-b636-e848024ec6d82025-11-18Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEA-S Medication Solutions0697b3cf-b146-47c0-b5a5-5905ae8d1c972025-11-18Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEVERITYRX, LLC427b6ffb-3ff4-932f-e063-6394a90ae8b92025-10-31Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
WastedBENZALKONIUM CHLORIDEFreshorize Ltd0c43b516-7608-c826-e063-6294a90ae4e32025-10-23WarningsExact identifier
unii: ZF94AP8MEY
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.b5653b7e-1e3b-4da3-b3a2-33318f448c672025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 863619
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.e466d963-469a-4b1c-87f9-2e3e1e9bdf3d2025-10-02Warnings, Adverse reactionsExact identifier
rxcui: 863619
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEMajor Pharmaceuticals7769ad3d-6228-4b2d-8f44-4efe990d3fad2025-09-19Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
Oxybutynin ChlorideOXYBUTYNIN CHLORIDECardinal Health 107, LLC8455b543-81ce-4522-ae9b-8396f944945c2025-08-18Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.8bd5dce0-d56a-4e64-8de7-e7cd7775526b2025-08-18Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ

Reported adverse events (FAERS/openFDA)#

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