FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
55648-433
11-digit product format
556480433
Labeler code
55648
Product ID
55648-433_ff0dc161-4748-415c-ba20-bdfff819c611
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA091231
Marketing category
ANDA
Marketing start
2011-01-19
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
E
Listing certified through
2018-12-31
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
55648-433-012020-01-31C16284748780-19d75b9cf-d958-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 Initial U.S. approval: 2000
55648-433-022020-01-31C16284748780-19d75b9cf-d958-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 Initial U.S. approval: 2000
55648-433-032020-01-31C16284748780-19d75b9cf-d958-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 Initial U.S. approval: 2000
55648-433-042020-01-31C16284748780-19d75b9cf-d958-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 Initial U.S. approval: 2000
55648-433-052020-01-31C16284748780-19d75b9cf-d958-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 Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-433-01PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE302
55648-433-02PANTOPRAZOLE SODIUM1000 in 1 BOTTLETABLET, DELAYED RELEASE10002
55648-433-03PANTOPRAZOLE SODIUM100 in 1 CARTONTABLET, DELAYED RELEASE1002
55648-433-03PANTOPRAZOLE SODIUM10 in 1 BLISTER PACKTABLET, DELAYED RELEASE102
55648-433-04PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE902
55648-433-05PANTOPRAZOLE SODIUM100 in 1 BOTTLETABLET, DELAYED RELEASE1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-433PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED]2Legacy NDC, 6 package rows20110128_ee114ab9-db51-4a71-90b9-cd9865e4fced.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNee114ab9-db51-4a71-90b9-cd9865e4fced2
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNee114ab9-db51-4a71-90b9-cd9865e4fced2
251872pantoprazole 20 MG Delayed Release Oral TabletSCDee114ab9-db51-4a71-90b9-cd9865e4fced2
314200pantoprazole 40 MG Delayed Release Oral TabletSCDee114ab9-db51-4a71-90b9-cd9865e4fced2
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYee114ab9-db51-4a71-90b9-cd9865e4fced2
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYee114ab9-db51-4a71-90b9-cd9865e4fced2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-433-015564804330130 in 1 BOTTLEHistorical
55648-433-02556480433021000 in 1 BOTTLEHistorical
55648-433-0355648043303100 in 1 CARTONHistorical
55648-433-045564804330490 in 1 BOTTLEHistorical
55648-433-0555648043305100 in 1 BOTTLEHistorical