FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
55154-4382
11-digit product format
551544382
Labeler code
55154
Product ID
55154-4382_44992b52-7e49-4f7d-878c-ff9ce5c24c66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090970
Marketing category
ANDA
Marketing start
2011-02-23
Substance
PANTOPRAZOLE SODIUM
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui314200

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4382-0Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE114
55154-4382-0Pantoprazole Sodium10 in 1 BAGTABLET, DELAYED RELEASE1014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4382PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH 107, LLC]12Current NDC, Legacy NDC, 2 package rows20241010_e17e4a72-d6a4-4a83-a921-88af9ef028a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNe17e4a72-d6a4-4a83-a921-88af9ef028a614
314200pantoprazole 40 MG Delayed Release Oral TabletSCDe17e4a72-d6a4-4a83-a921-88af9ef028a614
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYe17e4a72-d6a4-4a83-a921-88af9ef028a614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4382-05515443820010 BLISTER PACK in 1 BAG (55154-4382-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2011-02-230000-00-00NoNoCurrent