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 16 of 53 · 1,053 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WISH RUBBING ALCOHOL 91%ISOPROPYL ALCOHOLLJ Pharma07cba887-a568-4b92-91ab-2e7831f24ab52026-01-30WarningsExact identifier
unii: ND2M416302
Snap Labs Ammonia InhalantsAMMONIA INHALANTBrined LLC d/b/a Snap Labs4926daad-a250-a40a-e063-6394a90a95962026-01-30WarningsExact identifier
unii: 5138Q19F1X
Isopropyl AlcoholISOPROPYL ALCOHOLRite Aid Corporationc074bbaf-2fd7-485a-9e22-a368d8dd47012026-01-30Warnings, Adverse reactionsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 50%ISOPROPYL ALCOHOLLJ Pharma15b4a45d-3dbf-48e4-8f90-15dca7e650d92026-01-29WarningsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 50% Winter GreenISOPROPYL ALCOHOLLJ Pharmafbb45bde-b733-4524-bfa9-ae819ad399732026-01-29WarningsExact identifier
unii: ND2M416302
WalmartISOPROPYL ALCOHOLWalmart Inc.1d75799d-081e-a38b-e063-6294a90adf352026-01-29WarningsExact identifier
unii: ND2M416302
IRISISOPROPYL ALCOHOLAmerifoods Trading Co100e0c3d-96eb-44af-8684-df45a8ab30652026-01-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Isopropyl AlcoholISOPROPYL ALCOHOLBig Lots Stores, Inc.2c941c08-929c-43c9-966b-279086afca962026-01-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLBig Lots Stores, Inc.2ef87a8a-58be-4123-ad03-9891e6916f1a2026-01-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLCariba International001c1fcf-2808-467c-86d8-c038513fa3b52026-01-29WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLCariba International483586f4-aab4-40c2-8925-c4f7fb22c6aa2026-01-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Singular Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCac2b352f-6cb2-4683-bb41-13e8ecb186bf2026-01-27WarningsExact identifier
unii: ND2M416302
Snap Labs Ammonia InhalantsAMMONIA INHALANTBrined LLC d/b/a Snap Labs4927c18f-078e-94ec-e063-6394a90a4c6d2026-01-24WarningsExact identifier
unii: 5138Q19F1X
Everlit Survival Sting Relief PadISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a0414ea-f862-aa0f-e063-6294a90aecb72026-01-23WarningsExact identifier
unii: ND2M416302
EVERLIT SURVIVAL PREP PADISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a03ed81-5b1d-172e-e063-6394a90ac59c2026-01-23WarningsExact identifier
unii: ND2M416302
PANTOPRAZOLE SODIUMPANTOPRAZOLECamber Pharmaceuticals, Inc.9daa1483-5a36-44db-9e0d-904d100da2622026-01-22Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Rite Aid Isopropyl Alcohol WipesISOPROPYL ALCOHOLRite Aidbca837b0-5044-4e97-e053-2a95a90a13af2026-01-22WarningsExact identifier
unii: ND2M416302
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC6229247e-ee15-466e-a8ac-adcd646b738d2026-01-22Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Lights Isopropyl Alcohol Prep PadsISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4905a27c-6cf8-4b1a-a02c-4c81756e8c0a2026-01-21WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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