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 43 of 53 · 1,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.924a80b9-de48-90c0-e053-2995a90a00e12024-06-19Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 251872
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.8748a588-a1e5-9dfc-e053-2a95a90a846c2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.88f408cf-1b3e-4d7a-e053-2a95a90a369f2024-06-14Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs1680b4ed-d5b0-4fd9-b1d1-04df6a2138be2024-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 251872
unii: 6871619Q5X
SwabsISOPROPYL ALCOHOLMcKesson4650c945-8e38-5ad9-e054-00144ff8d46c2024-06-07WarningsExact identifier
unii: ND2M416302
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack7d51104d-b135-421f-8425-03b5772e71032024-05-20Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
IntimateNATRUM CARBONICUM, SACCHARUM OFFICINALE, LITHIUM CARBONICUM, PLACENTA TOTALIS SUIS, LAC CANINUM, ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, GERMANIUM METALLICUM, HELLEBORUS NIGER, MAGNESIA OXYDATA, RHUS GLABRA, STRAMONIUM, THUJA OCCIDENTALIS, DNA (HUMAN), OXYTOCIN, HYDROGEN, NEON, LAC MATERNA HUMANUMDeseret Biologicals, Inc.ca0447c1-606e-443a-b789-7d65143fec282024-05-13WarningsExact identifier
unii: 45P3261C7T
Debrox KidsISOPROPYL ALCOHOLMedtech Products Inc.f42eee70-c4ee-44ad-85d5-a06d98ecb8b02024-05-09WarningsExact identifier
unii: ND2M416302
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 6DC9Q167V3
Pantoprazole SodiumPANTOPRAZOLE SODIUMAsclemed USA, Inc.138b30cb-6b28-450e-9e7a-42576cc765452024-05-01Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMA-S Medication Solutions485212d4-caee-4a55-8299-87a28d6bd8f02024-04-29Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 314200
unii: 6871619Q5X
Isopropyl AlcoholISOPROPYL ALCOHOLJHK Incabae6a80-e859-47b5-8e34-d391eb8545832024-04-26WarningsExact identifier
unii: ND2M416302
PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication Solutions39ba58cc-e4ef-4b82-a0f3-9583fa123a382024-04-25Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEA-S Medication Solutions3a8fa326-ad75-4b6d-8832-0a2357eeca2f2024-04-25Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack3e5421ef-0875-4a04-b17d-95cca0052c832024-04-04Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEBryant Ranch Prepack617bb464-5357-472f-8e9d-61aae5b2ebef2024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
Isopropyl Alcohol Cleansing Pad TOALLITAS HUMEDAS CON ALCOHOL ISOPROPILICOISOPROPYL ALCOHOLM-star (Hubei) Health&Care Products Co., Ltd.42a482ab-2a62-4c39-8ea5-5e57ef794b8f2024-04-01WarningsExact identifier
unii: ND2M416302
Pantoprazole SodiumPANTOPRAZOLE SODIUMGolden State Medical Supply, Inc.d6aae78e-308b-7072-e053-2a95a90aaa102024-03-29Warnings, Adverse reactionsExact identifier
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
EdemaELAPS CORALLINUS, APIS MEL., ARSENICUM ALB., CANTHARIS, CINCHONA, COLCHICUM, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, JUNIPERUS COM., LACHESIS, MERC. VIV., NAJA, NAT. CARB., NAT.SULPHURICUM, RHUS TOXICODENDRON, SAMBUCUS NIG., STROPHANTHUS HISPIDUS, THUJA OCC., VIPERA BERUS, ECHINACEA, LAPPA, SOLIDAGO, TARAXACUM, URTICA UR.Newton Laboratories, Inc.14957500-1b2a-8427-e063-6394a90a371a2024-03-26WarningsExact identifier
unii: 45P3261C7T

Reported adverse events (FAERS/openFDA)#

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