FDA.reportPublic FDA data

NDC 68084-400-11 - 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
68084-400
Requested NDC
68084-400-11
Package NDCs from labels
68084-400-11, 68084-400-01
Manufacturer
American Health Packaging
Effective date
2022-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxybutynin Chloride - American Health PackagingAmerican Health Packaging2022-08-25HUMAN PRESCRIPTION DRUG LABEL
Oxybutynin Chloride - Cardinal HealthCardinal Health2020-09-15HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-400-01EA - Each68084-40041666e81-15c3-4690-94fc-d92d4134a63a12012-07-24
68084-400-11EA - Each68084-400b155c5bf-da98-4fc7-9851-e4e846ffd22d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYBUTYNIN CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]4
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]3
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYBUTYNIN CHLORIDE TABLET [CARDINAL HEALTH]3

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 1 of 5 · 94 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEREMEDYREPACK INC.1a08a16a-f16d-4ef1-95bb-6943bcae07372026-07-28Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDETruPharma LLC7c497c6c-2448-2c80-e053-2991aa0ab8c72026-07-27Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDERISING PHARMA HOLDINGS, INC.9578b6b8-5b9d-4263-9142-39b2c7216b852026-07-21Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEATLANTIC BIOLOGICALS CORP.fe4ed76b-0009-455f-be30-47e80fc1afdf2026-07-09Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDECoupler LLC55f618d1-4463-3200-e063-6394a90a89a82026-07-06Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEStrides Pharma Science Limited9ede5def-d185-4e40-9c10-8663ac654caf2026-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA075079
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAmerican Health Packaging0c71bdfb-01db-49ac-a8e9-0037df0d24af2026-06-24Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEStrides Pharma Science Limitedac10c7b7-d0cb-4068-93e2-c0e51f15866e2026-06-01Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.73d715dc-868d-4194-b668-4c39ababa6982026-05-20Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepacka5965c8b-179d-4665-8a3b-324b693607ee2026-05-19Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepack7db4ab81-b379-4a6d-b469-95eb9e184b562026-05-14Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAmerican Health Packaging4574b227-9726-4798-bac2-83bfb9616f092026-04-16Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEA-S Medication Solutionsb9d0e5c8-3a71-40a0-a7d3-44bc043392fa2026-02-17Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.a1f8be75-2eb9-4eef-8fb4-144ef2bf7ae12026-02-16Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.9a551ec5-7e80-47c9-a7b9-f458c14781742026-02-16Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEChartwell Governmental & Specialty RX, LLC.46e78c72-a5a3-472f-9125-b120fa4eee312026-01-30Adverse reactionsExact identifier
unii: L9F3D9RENQ
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPreferred Pharmaceuticals Inc.0e002fe8-fa3f-4a7d-84df-0c6e031e6ae42026-01-15Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ

Reported adverse events (FAERS/openFDA)#

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