FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
45865-622
11-digit product format
458650622
Labeler code
45865
Product ID
45865-622_9ab34397-58b8-74c5-e053-2995a90abd86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA077056
Marketing category
ANDA
Marketing start
2007-12-21
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
45865-622-302025-01-30C16284748780-12cef2736-6d4f-d83d-e063-dadaa90ab31fThese 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, for oral use Initial U.S. Approval: 2000
45865-622-602025-01-30C16284748780-12cef2736-6d4f-d83d-e063-dadaa90ab31fThese 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, for oral use Initial U.S. Approval: 2000
45865-622-902025-01-30C16284748780-12cef2736-6d4f-d83d-e063-dadaa90ab31fThese 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, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-622-30Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE302
45865-622-60Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE602
45865-622-90Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-622PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 3 package rows20191228_1f7fd914-08ee-664e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN1f7fd914-08ee-664e-e054-00144ff88e882
251872pantoprazole 20 MG Delayed Release Oral TabletSCD1f7fd914-08ee-664e-e054-00144ff88e882
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY1f7fd914-08ee-664e-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-622-304586506223030 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-622-30) 2015-09-110000-00-00NoNoCurrent
45865-622-604586506226060 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-622-60) 2015-09-110000-00-00NoNoCurrent
45865-622-904586506229090 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-622-90) 2007-12-210000-00-00NoNoCurrent