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 7 of 9 · 180 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepack246d2f79-8ab5-4023-9068-1451b695ac162024-10-03Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
oxybutyninOXYBUTYNINNCS HealthCare of KY, LLC dba Vangard Labsec4fd95f-16dc-4acf-b560-b67b7aaef08b2024-09-13Warnings, Adverse reactionsExact identifier
application number: ANDA202332
rxcui: 863619
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDETeva Pharmaceuticals USA, Inc.cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a292024-09-02Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDENuCare Pharmaceuticals,Inc.8e830697-a6d3-13ed-e053-2995a90acb112024-08-14Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutyninOXYBUTYNINNCS HealthCare of KY, LLC dba Vangard Labsed10f0c9-23d6-4ded-b17f-ed474632a9652024-08-12Warnings, Adverse reactionsExact identifier
application number: ANDA202332
rxcui: 863636
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEBryant Ranch Prepackf26e590d-956e-493b-a6ac-6056aeeaf4112024-08-09Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDERISING PHARMA HOLDINGS, INC.f8ed80f2-6c3d-4d7f-b761-c2447973c1f92024-07-03Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
oxybutynin chlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions7593becc-250f-4d25-8401-a9f72f3f5ad42024-06-03Warnings, Adverse reactionsExact identifier
rxcui: 863636
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions8f147f73-cfc6-40a3-b1a3-e4cab18685232024-06-03Warnings, Adverse reactionsExact identifier
rxcui: 863619
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions39a2d144-0c10-4aec-9fa4-0adc24b332eb2024-06-03Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEBryant Ranch Prepack169d6d58-8887-4bdd-95bd-873d1f049eaa2024-05-24Warnings, Adverse reactionsExact identifier
rxcui: 863619
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEProficient Rx LP7d2332b4-9e48-4bb2-a2c3-75e16e1d455b2024-04-01Warnings, Adverse reactionsExact identifier
rxcui: 863619
unii: L9F3D9RENQ
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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