NDC 80425-0406-01 - Pantoprazole Sodium DR

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
80425-0406
Requested NDC
80425-0406-01
Package NDCs from labels
80425-0406-3, 80425-0406-2, 80425-0406-1, 80425-0406-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-06-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pantoprazole Sodium DR - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-06-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0406-1Pantoprazole SodiumDR30 in 1 BOTTLETABLET, DELAYED RELEASE301
80425-0406-2Pantoprazole SodiumDR60 in 1 BOTTLETABLET, DELAYED RELEASE601
80425-0406-3Pantoprazole SodiumDR90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0406PANTOPRAZOLE SODIUM DR (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240704_1c46140c-2399-5ca3-e063-6394a90af33b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0406-1EA - Each80425-04064e172eaf-a599-46e3-9ba0-85df0805345d12024-08-12
80425-0406-2EA - Each80425-0406f1ce9817-2e14-419f-8ae8-17cb37ef38b912024-08-12
80425-0406-3EA - Each80425-0406eb55818d-1618-410f-80a8-549000c28edc12024-08-12

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 3 of 54 · 1,064 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smelling SaltAMMONIAShenzhen Jufeng Qisheng Technology Co., Ltd.44e1b2c1-f524-782c-e063-6394a90ad1e42026-08-18WarningsExact identifier
unii: 5138Q19F1X
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLThe Kroger Co.b127bba1-ce0b-4142-8b7d-f12f062b09382026-08-17Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.cd3f8779-9e57-4b23-a029-7424d4d4ab2a2026-08-17Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLThe Kroger Co.ca6c7f8a-d41a-4d77-817c-3dbdc40f890e2026-08-17Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Pantoprazole SodiumPANTOPRAZOLE SODIUMRedpharm Drug58d32be2-166e-1a64-e063-6394a90a26ea2026-08-12Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 314200
unii: 6871619Q5X
PantoprazolePANTOPRAZOLEPreferred Pharmaceuticals Inc.bb1e79ad-ff52-4696-8743-523f793b29d32026-08-11Warnings, Adverse reactionsExact identifier
rxcui: 251872
unii: 6871619Q5X
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: 45P3261C7T
LUXURY IPA 70%LUXURY ISOPROPYL ALCOHOL 70% 16OZTSM BRANDS LLC2240a9e0-dac5-54fa-e063-6394a90a35f52026-08-11WarningsExact identifier
unii: ND2M416302
PANTOPRAZOLE SODIUMPANTOPRAZOLEPreferred Pharmaceuticals Inc.5c14e2f3-625d-4089-a404-440b0ecf72e72026-08-11Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Pantoprazole SodiumPANTOPRAZOLE SODIUMAmerican Health Packaging5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452026-08-07Warnings, Adverse reactionsExact identifier
application number: ANDA202038
rxcui: 251872
rxcui: 314200
unii: 6871619Q5X
LIGHTS Antiseptic and Pain Relieving Prep PadISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.91cc7334-f610-487d-a895-3dda78c3372e2026-08-07WarningsExact identifier
unii: ND2M416302
CVS Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Pharmacy524605f9-8b04-b600-e063-6394a90a4a022026-08-07WarningsExact identifier
unii: ND2M416302
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Isopropyl alcohol 70 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLC57c496b3-10ab-4a72-8d8f-42a2256189dd2026-08-06WarningsExact identifier
unii: ND2M416302
PROHEAL ALCOHOL PREP PADSISOPROPYL ALCOHOLClick Industries LLCd272c1f6-e9c9-4099-9d24-f5aae44082ae2026-08-05WarningsExact identifier
unii: ND2M416302
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
Tazza Antiseptic Hand WipesISOPROPYL ALCOHOLTazza Brands East Inc.c37c7599-58b6-58bb-e053-2a95a90af1cf2026-08-04WarningsExact identifier
unii: ND2M416302
ADVOCATE Sterile Alcohol Prep PadsISOPROPYL ALCOHOLPHARMA SUPPLY, INCa87dd40d-a9b1-4bb5-acc2-2d00abc2034a2026-07-30WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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