Pantoprazole Sodium

Product NDC
67046-535
11-digit product format
670460535
Labeler code
67046
Product ID
67046-535_7c958802-daad-4c7e-88eb-73be7d2261d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
NDA020987
Marketing category
NDA
Marketing start
2010-02-26
Marketing end
0000-00-00
Substance
PANTOPRAZOLE SODIUM
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041Product name820260304
41d62193-73fc-49cf-9907-add9588e2da1Product name920260112
f12d0d0d-c068-46c6-872c-96c9d38533bbProduct name120250116
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-535-302019-10-21C16284748780-1956f9ecf-df17-621f-e053-dbdaa90a74adPantoprazole Sodium Delayed-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-535-30Pantoprazole SodiumDelayed-Release30 in 1 BLISTER PACKTABLET, DELAYED RELEASE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
Calcium StearateINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
CrospovidoneINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
HypromelloseINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
MannitolINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
PovidoneINACTIVE INGREDIENTFZ989GH94EPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
Sodium CarbonateINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-535PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100301_7c958802-daad-4c7e-88eb-73be7d2261d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN7c958802-daad-4c7e-88eb-73be7d2261d81
314200pantoprazole 40 MG Delayed Release Oral TabletSCD7c958802-daad-4c7e-88eb-73be7d2261d81
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY7c958802-daad-4c7e-88eb-73be7d2261d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-535-306704605353030 in 1 BLISTER PACKHistorical