FDA.reportPublic FDA data

Protonix

Product NDC
21695-108
11-digit product format
216950108
Labeler code
21695
Product ID
21695-108_cfeacb5c-8b1b-48f6-9acf-00044a8179b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazoel sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020987
Marketing category
NDA
Marketing start
2001-08-28
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
21695-108-152019-09-24C16284748780-1934fe258-47a9-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use PROTONIX safely and effectively. See full prescribing information for PROTONIX. PROTONIX (pantoprazole sodium) delayed-release tablets PROTONIX (pantoprazole sodium) for delayed-release oral suspension Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-108-15Protonix15 in 1 BOTTLETABLET, DELAYED RELEASE151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-108-15EA - Each21695-1089712077f-8c7f-4c4e-8b39-73de727bceac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-108PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110622_cfeacb5c-8b1b-48f6-9acf-00044a8179b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNcfeacb5c-8b1b-48f6-9acf-00044a8179b41
284400Protonix 40 MG Delayed Release Oral TabletPSNcfeacb5c-8b1b-48f6-9acf-00044a8179b41
284400pantoprazole 40 MG Delayed Release Oral Tablet [Protonix]SBDcfeacb5c-8b1b-48f6-9acf-00044a8179b41
314200pantoprazole 40 MG Delayed Release Oral TabletSCDcfeacb5c-8b1b-48f6-9acf-00044a8179b41
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYcfeacb5c-8b1b-48f6-9acf-00044a8179b41
284400Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYcfeacb5c-8b1b-48f6-9acf-00044a8179b41
284400Protonix 40 MG Delayed Release Oral TabletSYcfeacb5c-8b1b-48f6-9acf-00044a8179b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-108-152169501081515 in 1 BOTTLEHistorical