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 41 of 53 · 1,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Barbie ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.a4a6beb0-5781-4d74-9120-7ca64e035c232024-11-08WarningsExact identifier
unii: ND2M416302
MARVEL ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.f6cd4757-d6e0-46bd-827f-3f380c71858f2024-11-07WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadALCOHOL PREP PADASO LLC7481bfb9-2baf-b1ec-e053-2991aa0ad2de2024-11-01WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadALCOHOL PREP PADASO LLCf2a41151-a807-566c-e053-2995a90af8772024-11-01WarningsExact identifier
unii: ND2M416302
Pantoprazole SodiumPANTOPRAZOLE SODIUMCivica, Inc.c857dc41-7b47-4f26-a9f5-d76eb82b44ee2024-10-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
ProgeniteAMMONIUM CARBONICUM, BARYTA MURIATICA, BORAX, CAULOPHYLLUM THALICTROIDES, NATRUM CARBONICUM, SABAL SERRULATA, SABINA, SULPHURICUM ACIDUM, THIOSINAMINUM, FOLLICULINUM, TUBA UTERINA SUIS, UTERUS SUIS, HYPOTHALAMUS (SUIS), THYROIDINUM (SUIS), AGNUS CASTUS, CONIUM MACULATUM, GRAPHITES, HYOSCYAMUS NIGER, SEPIA, SELENIUM METALLICUM, X-RAYDeseret Biologicalsdfc114e0-34d4-4ae4-bba8-a8a1b7ad6a242024-10-23WarningsExact identifier
unii: 45P3261C7T
Isopropyl Rubbing Alcohol 99%ISOPROPYL ALCOHOLUniversal Distribution Center LLC678a9b14-2838-4358-9673-fc23e0f58efb2024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLCa9960d2f-f13a-4168-b2e9-d6f4a35d84ae2024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLUniversal Distribution Center LLC5db1659e-3a13-47f0-90ae-f8f192c6111a2024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70% with WintergreenISOPROPYL ALCOHOLUniversal Distribution Center LLC3dcdc1cc-ece8-4b47-a236-ee57c375bb992024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 50% with WintergreenISOPROPYL ALCOHOLUniversal Distribution Center LLC0b185535-b1af-4128-89ca-65b0e63cd4302024-10-21WarningsExact identifier
unii: ND2M416302
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
unii: 1K09F3G675
Genuine First Aid Alcohol Cleansing PadISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.af090168-f9b3-c2fa-e053-2a95a90a1b762024-10-15WarningsExact identifier
unii: ND2M416302
Isopropyl Alcohol Cleansing PadISOPROPYL ALCOHOLHubei Changjian Medical Products Co., Ltd.e6f9a23b-ae6e-4fce-b66d-b602038dc7462024-10-11WarningsExact identifier
unii: ND2M416302
EsteemAMBRA GRISEA, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, VISCUM ALBUM, THUJA OCCIDENTALIS, HYPOTHALAMUS SUIS, CUBEBA OFFICINALIS, AGNUS CASTUS, ANACARDIUM ORIENTALE, BARYTA IODATA, LAC CANINUM, NAJA TRIPUDIANS, RHUS GLABRA, ROSA DAMASCENA, SABADILLA, AURUM METALLICUM, LAC FELINUM, MAGNESIUM IODIDE, CARCINOSINDeseret Biologicals, Inc.2946e748-85a9-4398-b4b6-81aa0f3ebe692024-10-04WarningsExact identifier
unii: 45P3261C7T
Isopropyl AlcoholISOPROPYL ALCOHOLBecton Dickinson and Company7ae72375-ffed-42c8-9506-051861ea68fc2024-10-03WarningsExact identifier
unii: ND2M416302
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.a9f32edf-e0b9-4e96-e053-2a95a90afbc82024-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole sodiumPANTOPRAZOLE SODIUMAmerican Health Packaging423dac8b-bb1e-4456-9b6e-913c028b11bc2024-10-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 6DC9Q167V3
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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