FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
50436-8102
11-digit product format
504368102
Labeler code
50436
Product ID
50436-8102_4e19dea0-3cdd-4454-bca1-471c47ddb09c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
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
No
Listing certified through
2020-12-31
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
50436-8102-22021-01-29C16284748780-1ba0f9c33-1a2d-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-8102-2PANTOPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-8102-2EA - Each50436-81020b061b74-6c81-4f55-ac99-8e2764a32b1f12015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-8102PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]4Legacy NDC, 1 package rows20190106_e483f0bc-9aff-46a9-baa2-d4e558c62b57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNe483f0bc-9aff-46a9-baa2-d4e558c62b574
251872pantoprazole 20 MG Delayed Release Oral TabletSCDe483f0bc-9aff-46a9-baa2-d4e558c62b574
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYe483f0bc-9aff-46a9-baa2-d4e558c62b574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-8102-25043681020260 in 1 BOTTLEHistorical