FDA.reportPublic FDA data

NDC 0338-9644-01 - 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
0338-9644
Requested NDC
0338-9644-01
Package NDCs from labels
0338-9644-01, 0338-9644-12
Manufacturer
Baxter Healthcare Company | Baxter Healthcare Corporation
Effective date
2024-02-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PANTOPRAZOLE SODIUM - Baxter Healthcare Company | Baxter Healthcare CorporationBaxter Healthcare Company | Baxter Healthcare Corporation2024-02-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-9644-01PANTOPRAZOLE SODIUM100 mL in 1 BAGINJECTION, SOLUTION1004
0338-9644-12PANTOPRAZOLE SODIUM12 in 1 CARTONINJECTION, SOLUTION124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9644PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]4Current NDC, 2 package rows20250109_a476e063-9450-4793-9a22-16b0a0a61cd0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9644-01ML - Milliliter0338-964427b344f3-899f-48da-b291-0ecd865fb8de12024-12-10
0338-9644-12ML - Milliliter0338-9644f7ca272a-a1f6-4faf-a96d-e9d9c256aa3d12024-08-12

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 40 of 59 · 1,164 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC83994d0c-8484-4505-abb5-8a384ed122882024-07-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.b2abc159-e450-99dc-e053-2a95a90abe6a2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals, Inc.4fbec80c-b38d-122c-e054-00144ff88e882024-07-15Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
sodium chlorideSODIUM CHLORIDEBecton Dickinson and Company8df7dcf6-8714-6caf-e053-2995a90ab8cc2024-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LP50a278de-bd16-417c-a741-81bfe0d745f22024-07-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx of Tennessee, LLC1c46140c-2399-5ca3-e063-6394a90af33b2024-06-27Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Sodium ChlorideSODIUM CHLORIDECODAN US CORPORATIONaa06e286-75c6-4d7a-959f-6008d38aa6e52024-06-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.924a80b9-de48-90c0-e053-2995a90a00e12024-06-19Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
PANTOPRAZOLE SODIUMPANTOPRAZOLENuCare Pharmaceuticals,Inc.8748a588-a1e5-9dfc-e053-2a95a90a846c2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.88f408cf-1b3e-4d7a-e053-2a95a90a369f2024-06-14Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Derma Pain PlusCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)Peaceful Mountain, Inc.6fa79c31-e48e-4c83-baa2-96cef22cfee12024-06-13WarningsExact identifier
unii: 451W47IQ8X
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: 451W47IQ8X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs1680b4ed-d5b0-4fd9-b1d1-04df6a2138be2024-06-12Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
NATRUM MURNATRUM MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a22655a-68f3-4f13-e063-6294a90ae52c2024-06-05WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mentox HPAURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.ebb23637-4931-4563-ab30-99bea02765802024-05-28WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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