FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
43353-027
11-digit product format
433530027
Labeler code
43353
Product ID
43353-027_244f530f-f490-4ad9-ad20-bf541fb4f95f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078281
Marketing category
ANDA
Marketing start
2011-01-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui251872, 314200

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
43353-027-30Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE303
43353-027-53Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE603
43353-027-60Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE903
43353-027-80Pantoprazole Sodium180 in 1 BOTTLETABLET, DELAYED RELEASE1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-027-30EA - Each43353-0279b73a8ca-359e-4c9d-a265-f8e477ca954012016-07-19
43353-027-53EA - Each43353-027853c4d75-c62a-48bc-bbe2-47e45081243e12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-027PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 4 package rows20171024_c9bc288b-e84c-4e31-a769-c87a59226086.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNc9bc288b-e84c-4e31-a769-c87a592260863
251872pantoprazole 20 MG Delayed Release Oral TabletSCDc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole 40 MG Delayed Release Oral TabletSCDc9bc288b-e84c-4e31-a769-c87a592260863
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYc9bc288b-e84c-4e31-a769-c87a592260863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-027-304335300273030 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-30) 2015-04-290000-00-00NoNoCurrent
43353-027-534335300275360 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-53) 2015-04-290000-00-00NoNoCurrent
43353-027-604335300276090 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-60) 2016-04-190000-00-00NoNoCurrent
43353-027-8043353002780180 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-80) 2016-04-190000-00-00NoNoCurrent