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 34 of 53 · 1,053 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)afe23634-27a4-46cf-b428-8fa3a274712c2025-04-09WarningsExact identifier
unii: ND2M416302
Isopropyl Alcohol 91 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)3c70ba1c-b12f-4a98-b993-1179ebe3e0702025-04-09WarningsExact identifier
unii: ND2M416302
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM INJECTIONAlembic Pharmaceuticals Limited02ee7ed6-217f-4128-bbbb-b9390475a65b2025-04-07Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
MEDI-FIRST First Aid AntisepticISOPROPYL ALCOHOLUltra Distributors Incb6c88941-9982-3a37-e053-2995a90a8a5a2025-04-07WarningsExact identifier
unii: ND2M416302
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM INJECTIONAlembic Pharmaceuticals Inc.a9e5fac6-2db6-4311-a98b-eb3f0dde19d62025-04-07Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMRising Pharma Holdings, Inc.91a6b13f-457f-4136-9541-c4adb9c3c35c2025-04-02Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMAurobindo Pharma Limitedb3cec41e-e98b-470a-8ba2-c315370239892025-04-02Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed releasePANTOPRAZOLE SODIUM GRANULESCipla USA Inc.195e06db-b76c-4470-b6a5-a3979c25046d2025-04-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
SaniiswabISOPROPYL ALCOHOLPOLLEY MED LLC303b1ad5-a104-3479-e063-6294a90abcde2025-03-20WarningsExact identifier
unii: ND2M416302
HypothaltemEUPATORIUM PERFOLIATUM, BERBERIS VULGARIS, MENTHA PULEGIUM, MOSCHUS, BENZINUM, SEPIA, BARYTA CARBONICA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, THYROIDINUM (SUIS), PYRIDOXINUM HYDROCHLORICUM, GELSEMIUM SEMPERVIRENS, NATRUM CARBONICUM, NUX VOMICA, STAPHYSAGRIANucleic Products, LLCb95050f2-f40d-4e84-8752-4d7ad75390c92025-03-20WarningsExact identifier
unii: 45P3261C7T
Pantoprazole SodiumPANTOPRAZOLE SODIUMA-S Medication Solutions81696241-17d5-4d35-9e59-8c28469ffd2c2025-03-14Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
unii: 1K09F3G675
Pantoprazole SodiumPANTOPRAZOLE SODIUMMeitheal Pharmaceuticals Inc.c18aff31-f91e-4b6a-9713-52c9094c60822025-03-13Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole sodiumPANTOPRAZOLE SODIUMBE Pharmaceuticals Inc.52d5bc28-66df-43aa-bb1a-8ac4a2a7f6932025-03-07Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
unii: ND2M416302
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
Bestmade Natural Products BM212ARS ALB, KALI PHOS, NAT CARB, NITRIC ACIDBestmade Natural Products2f37416e-b3af-f980-e063-6294a90a6be12025-02-28WarningsExact identifier
unii: 45P3261C7T

Reported adverse events (FAERS/openFDA)#

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