FDA.reportPublic FDA data

Pantoprazole

Product NDC
53808-1081
11-digit product format
538081081
Labeler code
53808
Product ID
53808-1081_5381ed3f-3485-4c31-aac4-34a168296844
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077619
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
PANTOPRAZOLE SODIUM
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
53808-1081-12020-01-31C16284748780-19d75b9d1-0945-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use pantoprazole sodium delayed-release tablets USP safely and effectively. See full prescribing information for pantoprazole sodium delayed-release tablets USP. PANTOPRAZOLE Sodium delayed-release tablets USP for oral use Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1081-1Pantoprazole30 in 1 BLISTER PACKTABLET, DELAYED RELEASE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ZEININACTIVE INGREDIENT80N308T1NNPANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1081PANTOPRAZOLE TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20150120_df37e937-6062-47bd-99ea-6ece768daa92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNdf37e937-6062-47bd-99ea-6ece768daa921
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNdf37e937-6062-47bd-99ea-6ece768daa921
251872pantoprazole 20 MG Delayed Release Oral TabletSCDdf37e937-6062-47bd-99ea-6ece768daa921
314200pantoprazole 40 MG Delayed Release Oral TabletSCDdf37e937-6062-47bd-99ea-6ece768daa921
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYdf37e937-6062-47bd-99ea-6ece768daa921
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYdf37e937-6062-47bd-99ea-6ece768daa921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-1081-15380810810130 in 1 BLISTER PACKHistorical