FDA.reportPublic FDA data

NDC 50090-5378-01 - Pantoprazole Sodium

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
50090-5378
Requested NDC
50090-5378-01
Package NDCs from labels
50090-5378-0, 50090-5378-1, 50090-5378-01
Manufacturer
A-S Medication Solutions
Effective date
2023-07-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pantoprazole Sodium - A-S Medication SolutionsA-S Medication Solutions2023-07-31Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5378-02023-02-07These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
50090-5378-12023-02-07These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
50090-5378-02023-01-30These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
50090-5378-12023-01-30These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5378-0Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE307
50090-5378-1Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5378PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230801_f1eb666a-120d-47fd-8c9f-73cef839294a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5378-0EA - Each50090-537867b3afa8-9d9e-4fb0-8ef6-b892ccb911ee12022-12-07
50090-5378-1EA - Each50090-537879d7cf20-3cb6-4885-874a-2fb05e0e134012023-04-07

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 39 of 53 · 1,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5ee961-1d64-0d9d-e053-2a95a90a60102024-12-18WarningsExact identifier
unii: ND2M416302
70% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLSZY Holdings, LLC dba EverReady First Aid1e39b0f4-66d1-47ac-aed6-d6ac019888ce2024-12-18WarningsExact identifier
unii: ND2M416302
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5eb0df-cd2d-691c-e053-2995a90a25112024-12-18WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLFirst Aid Research Corp.7d1c0382-31b3-48d0-a514-c5cc45a2299e2024-12-18WarningsExact identifier
unii: ND2M416302
Global EASY PREP alcohol prep padsISOPROPYL ALCOHOLGlobal Diabetic Distributorsa424b431-bf9c-4025-92a7-9d0b8a934c362024-12-18WarningsExact identifier
unii: ND2M416302
OIDO SANAISOPROPYL ALCOHOLProMex LLC71e84695-49e8-459f-ac5e-118b5235fe062024-12-18WarningsExact identifier
unii: ND2M416302
Curaplex Alcohol Prep PadISOPROPYL ALCOHOLSarnova, Inc.da1a4baa-05eb-4a75-82bb-39c547daef642024-12-12WarningsExact identifier
unii: ND2M416302
NEXXGEN 70% RUBBING ALCOHOL with WintergreenISOPROPYL ALCOHOLA & A Nexxgen LLC8d1a5c98-8169-4f40-8601-a6f6bbbbebe72024-12-09WarningsExact identifier
unii: ND2M416302
NEXXGEN 91% RUBBING ALCOHOL with WintergreenISOPROPYL ALCOHOLA & A Nexxgen LLC12b8c85a-da0c-47a1-9531-c9f2858c4f312024-12-09WarningsExact identifier
unii: ND2M416302
NEXXGEN 91% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLC609267da-3ee6-4bd3-aecf-610d9047774c2024-12-09WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLSarnova, Inc.62be13a6-da24-4ab0-b0f4-f2894324c20c2024-12-06WarningsExact identifier
unii: ND2M416302
ALPET E3 HAND SANITIZERISOPROPYL ALCOHOLBest Sanitizers, Inc.08055e08-039d-43da-adad-adaf6639fa842024-12-05WarningsExact identifier
unii: ND2M416302
Walgreens 70% Isopropyl AlcoholISOPROPYL ALCOHOLWalgreen Co.21f125a0-73e8-34a9-e063-6294a90a83962024-12-04WarningsExact identifier
unii: ND2M416302
First Aid Antiseptic Isopropyl Alcohol PadISOPROPYL ALCOHOLFourstar Group USA, Inc.27edf5dc-3e68-bdd0-e063-6394a90ac4852024-11-27WarningsExact identifier
unii: ND2M416302
First Aid Only Alcohol Antiseptic PadALCOHOL PADAcme United Corporation55421010-d806-4ca4-e054-00144ff88e882024-11-26WarningsExact identifier
unii: ND2M416302
Wipesplus Hand Sanitizing WipesISOPRPOYL ALCOHOLAcme United Corporatione7272bea-04ac-59c2-e053-2a95a90a2e0c2024-11-26WarningsExact identifier
unii: ND2M416302
First Aid Only Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporationd71047f6-1353-c758-e053-2995a90a962c2024-11-26WarningsExact identifier
unii: ND2M416302
First Aid Only Hand Sanitizing WipeISOPROPYL ALCOHOLAcme United Corporation03ec9021-816f-970c-e063-6294a90a67322024-11-26WarningsExact identifier
unii: ND2M416302
First Aid Only Alcohol Antiseptic PadISOPROPYL ALCOHOLAcme United Coporationa01fec1b-1339-40b9-e053-2995a90aeda52024-11-23WarningsExact identifier
unii: ND2M416302
Med-Nap Sterile Alcohol Prep PadsISOPROPYL ALCOHOLAcme United Corporationc6eff57b-d537-69c8-e053-2a95a90adc3a2024-11-23WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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