FDA.reportPublic FDA data

NDC 70954-005-40 - 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
70954-005
Requested NDC
70954-005-40
Package NDCs from labels
70954-005-10, 70954-005-20, 70954-005-30, 70954-005-40, 70954-005-50
Manufacturer
Northwind Health Company, LLC
Effective date
2026-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxybutynin Chloride - Northwind Health Company, LLCNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - VERITYRX, LLCVERITYRX, LLC2025-10-31HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - Major PharmaceuticalsMajor Pharmaceuticals2025-09-19HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride Tablets, USP Rx onlyGolden State Medical Supply, Inc.2024-12-23HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - ANI Pharmaceuticals, Inc. | Novitium Pharma LLCANI Pharmaceuticals, Inc. | Novitium Pharma LLC2024-11-25Human Prescription Drug Label
Oxybutynin Chloride Tablets, USP 5 mg Rx onlyNuCare Pharmaceuticals,Inc.2024-08-14HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride Tablets, USP Rx onlyREMEDYREPACK INC.2024-06-18HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - A-S Medication SolutionsA-S Medication Solutions2023-12-27Human Prescription Drug Label
Oxybutynin Chloride - A-S Medication SolutionsA-S Medication Solutions2023-12-27Human Prescription Drug Label
Oxybutynin Chloride - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2023-01-12HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - Bryant Ranch PrepackBryant Ranch Prepack2021-12-28HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2020-01-30HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - Marlex Pharmaceuticals IncMarlex Pharmaceuticals Inc2019-10-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-005-10Oxybutynin Chloride100 in 1 BOTTLETABLET1004
70954-005-20Oxybutynin Chloride500 in 1 BOTTLETABLET5004
70954-005-30Oxybutynin Chloride1000 in 1 BOTTLETABLET10004
70954-005-40Oxybutynin Chloride1 in 1 BLISTER PACKTABLET14
70954-005-50Oxybutynin Chloride100 in 1 CARTONTABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-005OXYBUTYNIN CHLORIDE TABLET [ANI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 5 package rows20241127_3b1f5585-9b33-4a96-bf33-8e6bab14bf0c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-005-10EA - Each70954-005578dfbca-9e3c-4f4d-942f-e7a4d331a0dd12018-01-12
70954-005-20EA - Each70954-005ca724434-4206-4756-9065-a38e6252df4912018-01-12
70954-005-30EA - Each70954-005ad034756-247c-496f-a21a-aae5cc3291d812018-01-12

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 4 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDERISING PHARMA HOLDINGS, INC.f8ed80f2-6c3d-4d7f-b761-c2447973c1f92024-07-03Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions7593becc-250f-4d25-8401-a9f72f3f5ad42024-06-03Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions8f147f73-cfc6-40a3-b1a3-e4cab18685232024-06-03Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions39a2d144-0c10-4aec-9fa4-0adc24b332eb2024-06-03Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEBryant Ranch Prepack169d6d58-8887-4bdd-95bd-873d1f049eaa2024-05-24Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEProficient Rx LP7d2332b4-9e48-4bb2-a2c3-75e16e1d455b2024-04-01Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEBryant Ranch Prepack2f898b29-46cf-4427-bb64-8c30532222f52024-01-18Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutions5e3b454b-6d3c-418b-8ac2-b0e17f018bbf2023-12-27Warnings, Adverse reactionsExact identifier
application number: ANDA209823
ndc (package): 50090-6966-3
ndc (package): 50090-6966-0
ndc (package): 50090-6966-1
ndc (product): 50090-6966
rxcui: 863664
spl id: 152bdcf5-866b-47c5-a491-c6595c2bc4ff
spl set id: 5e3b454b-6d3c-418b-8ac2-b0e17f018bbf
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEA-S Medication Solutionsafc6a3aa-e43d-4f10-bdbd-570a149bf9db2023-12-27Warnings, Adverse reactionsExact identifier
application number: ANDA209823
ndc (package): 50090-6967-0
ndc (product): 50090-6967
rxcui: 863664
spl id: a88c7b98-1c1f-4512-85a7-bf2b5d835220
spl set id: afc6a3aa-e43d-4f10-bdbd-570a149bf9db
unii: L9F3D9RENQ
oxybutyninOXYBUTYNINZydus Pharmaceuticals USA Inc.c042bf06-79a3-4dc7-ae05-3ef3cfae9d442023-11-07Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEA-S Medication Solutions83522acd-0ecc-46ac-a018-a3205ba096ff2023-11-01Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDENCS HealthCare of KY, LLC dba Vangard Labs5b72d34e-ae57-4459-ba2c-3bae8a69c5c12023-10-04Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a2023-05-31Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLCd2bb6927-5fbf-49ca-a891-d701bff1c8122023-05-31Warnings, Adverse reactionsExact identifier
application number: ANDA209823
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDELannett Company, Inc.c5950dba-d92b-46a0-993f-af9f9ddb52bf2023-05-30Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutyninOXYBUTYNINA-S Medication Solutions1f95920c-5dc2-44e4-b61d-b2c5e05390ba2023-02-06Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAmneal Pharmaceuticals LLC53924eba-1919-4203-9a1e-d57dfdd3b9632023-02-02Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
f216d9ff-5324-0530-e053-2a95a90a0af3cdc92bc6-f4d4-45bf-e053-2a95a90a67472023-01-12Warnings, Adverse reactionsExact identifier
spl id: f216d9ff-5324-0530-e053-2a95a90a0af3
spl set id: cdc92bc6-f4d4-45bf-e053-2a95a90a6747
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAphena Pharma Solutions - Tennessee, LLC1e1c1043-e4c5-4a06-9cc1-45d4397746f42023-01-04Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEProficient Rx LPe3f0c249-8085-4979-823a-820e233a284f2022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ

Reported adverse events (FAERS/openFDA)#

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