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 9 of 9 · 180 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: FZ989GH94E
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: FZ989GH94E
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
unii: 3NXW29V3WO
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: FZ989GH94E
oxybutyninOXYBUTYNINZydus Pharmaceuticals USA Inc.c042bf06-79a3-4dc7-ae05-3ef3cfae9d442023-11-07Warnings, Adverse reactionsExact identifier
application number: ANDA202332
rxcui: 863636
rxcui: 863619
rxcui: 863628
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEA-S Medication Solutions83522acd-0ecc-46ac-a018-a3205ba096ff2023-11-01Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDENCS HealthCare of KY, LLC dba Vangard Labs5b72d34e-ae57-4459-ba2c-3bae8a69c5c12023-10-04Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: ZF94AP8MEY
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2023-05-31Warnings, Adverse reactionsExact identifier
rxcui: 863636
rxcui: 863619
rxcui: 863628
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLCd2bb6927-5fbf-49ca-a891-d701bff1c8122023-05-31Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDELannett Company, Inc.c5950dba-d92b-46a0-993f-af9f9ddb52bf2023-05-30Warnings, Adverse reactionsExact identifier
rxcui: 863636
rxcui: 863619
rxcui: 863628
unii: L9F3D9RENQ
oxybutyninOXYBUTYNINA-S Medication Solutions1f95920c-5dc2-44e4-b61d-b2c5e05390ba2023-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA202332
rxcui: 863619
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAmneal Pharmaceuticals LLC53924eba-1919-4203-9a1e-d57dfdd3b9632023-02-02Warnings, Adverse reactionsExact identifier
rxcui: 863636
rxcui: 863619
rxcui: 863628
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC1e1c1043-e4c5-4a06-9cc1-45d4397746f42023-01-04Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEProficient Rx LPe3f0c249-8085-4979-823a-820e233a284f2022-06-01Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEProficient Rx LP88f08450-559e-4038-aad1-051e4ab283cf2022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 863619
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDELeading Pharma, LLCb73b8338-8045-448f-87a6-3d289227d00e2022-02-14Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDELannett Company, Inc.615f3d95-197c-4fec-b81f-c26449c93c3b2020-02-21Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLCe985e201-2fb3-4781-9790-a1a3db1ae2a12017-10-20Warnings, Adverse reactionsExact identifier
rxcui: 863636
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC58136f28-70c1-4cf2-bcd7-858c5609431a2016-06-15Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ

Reported adverse events (FAERS/openFDA)#

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