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 6 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDERising Pharma Holdings, Inc.ab431781-3183-4638-b656-f40a61f079402025-05-19Warnings, Adverse reactionsExact identifier
rxcui: 863636
rxcui: 863619
rxcui: 863628
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAvKARE3418ca19-feb0-9821-e063-6394a90ae8192025-05-01Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAvPAK242b4766-bc2b-0073-d72d-1bf879bbee242025-04-17Warnings, Adverse reactionsExact identifier
rxcui: 863636
rxcui: 863619
rxcui: 863628
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.9c8ced4b-94de-4df8-bea3-b42b8846b7692025-03-12Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.0c021aad-97a3-4404-a11e-cdd2ec731c6b2025-03-07Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.3a319017-4e25-402e-8ba0-63b9f1eb707e2025-02-27Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEChartwell RX, LLCd02e411b-2f34-4d08-a92a-9762cab472692025-02-26Adverse reactionsExact identifier
unii: L9F3D9RENQ
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepackf92cf6d0-5f49-40e2-a4f4-8ff377cacbfb2025-01-30Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDERedpharm Drugfc4cfbe6-a940-41c0-e053-6294a90adb142025-01-23Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEdirect rxb3d6d2a8-97c4-5bad-e053-2a95a90a155d2025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 863636
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEDIRECT RXada3be87-2cdd-75f7-e053-2995a90aa95b2025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 863619
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEGolden State Medical Supply, Inc.6f409d7f-b064-1363-e053-2a91aa0a3a142024-12-23Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEKVK-Tech, Inc.f99fdfe8-a980-4a72-bc99-aa2ce0bdfd862024-12-06Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutyninOXYBUTYNINZydus Lifesciences Limitedf405a774-bd91-4513-b7c7-c44f0596d9882024-12-03Exact identifier
application number: ANDA202332
ndc (package): 70771-1086-1
ndc (package): 70771-1087-3
ndc (package): 70771-1088-3
ndc (package): 70771-1087-6
ndc (package): 70771-1086-6
ndc (package): 70771-1087-5
ndc (package): 70771-1088-1
ndc (package): 70771-1088-6
ndc (package): 70771-1086-9
ndc (package): 70771-1088-4
ndc (package): 70771-1086-3
ndc (package): 70771-1088-5
ndc (package): 70771-1087-9
ndc (package): 70771-1087-2
ndc (package): 70771-1088-9
ndc (package): 70771-1086-5
ndc (package): 70771-1087-1
ndc (package): 70771-1088-2
ndc (package): 70771-1086-2
ndc (package): 70771-1087-4
ndc (package): 70771-1086-4
ndc (product): 70771-1087
ndc (product): 70771-1086
ndc (product): 70771-1088
ndc11 (package): 70771108702
rxcui: 863636
rxcui: 863619
rxcui: 863628
spl id: e2d9aa83-078e-4c67-a9d0-8c166bc4d9f0
spl set id: f405a774-bd91-4513-b7c7-c44f0596d988
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEANI Pharmaceuticals, Inc.3b1f5585-9b33-4a96-bf33-8e6bab14bf0c2024-11-25Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC2425f49f-ade3-5178-e063-6294a90adfac2024-10-10Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ

Reported adverse events (FAERS/openFDA)#

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