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 45 of 53 · 1,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer 70 Isopropyl Alcohol Wipes First Aid AntisepticISOPROPYL ALCOHOLMeijer, Inc2046162f-cb70-416c-ae37-14999883a8072024-01-09WarningsExact identifier
unii: ND2M416302
A03 ULTRA ANTITOXALFALFA, AMERICAN GINSENG, APIS MELLIFICA, ASPARAGUS OFFICINALIS, AVENA SATIVA, BARYTA IODATA, BERBERIS VULGARIS, BRYONIA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, CONIUM MACULATUM, FERRUM IODATUM, LAPIS ALBUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, PASSIFLORA INCARNATA, SCROPHULARIA NODOSA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA URSIApex Energetics Inc.b945cb81-aee4-38e8-e053-2a95a90aa8df2024-01-08WarningsExact identifier
unii: 45P3261C7T
Harris Teeter Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLHarris Teeter, LLC.31ac6883-ffc6-39de-e063-6294a90a52dd2024-01-01WarningsExact identifier
unii: 6DC9Q167V3
Exchange Select High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArmy and Air Force Exchange Service31ac8bd2-c2e9-6f2c-e063-6394a90adc722024-01-01WarningsExact identifier
unii: 6DC9Q167V3
CVS Health Fast Acting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVS Pharmacy, Inc.31addfd2-52f2-05b3-e063-6294a90a337f2024-01-01WarningsExact identifier
unii: 6DC9Q167V3
Alcohol PrepISOPROPYL ALCOHOLTopco Associates65270825-48b1-49e7-a14e-f73df9beb9dd2023-12-27WarningsExact identifier
unii: ND2M416302
Ear Drops for SwimmersISOPROPYL ALCOHOLPharma Nobis, LLCe42fd693-24ab-0fc0-e053-2995a90ab9542023-12-26WarningsExact identifier
unii: ND2M416302
Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e1-02c6-e053-2995a90a3ace2023-12-26WarningsExact identifier
unii: ND2M416302
Equate Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWal-Mart Stores, Inc.91f85a72-5270-e4db-e053-2995a90aeb212023-12-23WarningsExact identifier
unii: 6DC9Q167V3
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWal-Mart Stores, Inc.e32233ef-ea15-45b8-8e83-b658cf4c56a02023-12-23WarningsExact identifier
unii: 6DC9Q167V3
Sunmark Lubricant Eye DropsPOLYPROPYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCb117ff0a-1a48-4022-96e6-52bc45f056fc2023-12-23WarningsExact identifier
unii: 6DC9Q167V3
Sunmark Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC58f0b6d7-6072-40fd-ba72-b3ed688347912023-12-23WarningsExact identifier
unii: 6DC9Q167V3
Signature Care Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands, LLC05a63929-fccd-2936-e063-6294a90aeac52023-12-23WarningsExact identifier
unii: 6DC9Q167V3
LEADER Ear Drops for SwimmersLEADER EAR DROPS FOR SWIMMERSCardinal Health, 110 dba Leader874857eb-2a9d-6ef7-e053-2995a90af1562023-12-22WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70 PercentISOPROPYL ALCOHOLPharma Nobis, LLCe42f727c-beb0-fe9d-e053-2995a90aafea2023-12-22WarningsExact identifier
unii: ND2M416302
Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e0-02c6-e053-2995a90a3ace2023-12-22WarningsExact identifier
unii: ND2M416302
Meijer Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.9feadde4-fbe5-0c9e-e053-2995a90a9b302023-12-22WarningsExact identifier
unii: 6DC9Q167V3
Meijer Ultra Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.a0846e3e-687c-fd55-e053-2995a90a673e2023-12-22WarningsExact identifier
unii: 6DC9Q167V3
NUMSTAT Antiseptic and Pain Relieving Prep PadALCOHOL, MENTHOL, AND BENZOCAINE PREP PADSpectra Medical Devices, LLC07d20040-9dd9-0aba-e063-6294a90ab7cf2023-12-20WarningsExact identifier
unii: ND2M416302
Health Mart Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLStrategic Sourcing Services LLCfbd2aa69-b1c7-4a28-9642-a436ae09faaf2023-12-20WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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