FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
71335-1572
11-digit product format
713351572
Labeler code
71335
Product ID
71335-1572_79deea3c-88e7-40f8-910f-644c1cf65f05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202882
Marketing category
ANDA
Marketing start
2014-09-10
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
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 SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui251872

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
71335-1572-1PANTOPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE60106
71335-1572-2PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE30106
71335-1572-3PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE90106
71335-1572-4PANTOPRAZOLE SODIUM56 in 1 BOTTLETABLET, DELAYED RELEASE56106
71335-1572-5PANTOPRAZOLE SODIUM28 in 1 BOTTLETABLET, DELAYED RELEASE28106
71335-1572-6PANTOPRAZOLE SODIUM10 in 1 BOTTLETABLET, DELAYED RELEASE10106
71335-1572-7PANTOPRAZOLE SODIUM120 in 1 BOTTLETABLET, DELAYED RELEASE120106
71335-1572-8PANTOPRAZOLE SODIUM180 in 1 BOTTLETABLET, DELAYED RELEASE180106
71335-1572-9PANTOPRAZOLE SODIUM3 in 1 BOTTLETABLET, DELAYED RELEASE3106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1572-1EA - Each71335-15725e6f29ca-e883-4cf5-ae60-1195935e003312020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1572PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 9 package rows20240410_fa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNfa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a106
251872pantoprazole 20 MG Delayed Release Oral TabletSCDfa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a106
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYfa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1572-17133515720160 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1572-1) 2020-04-230000-00-00NoNoCurrent
71335-1572-27133515720230 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1572-2) 2020-05-290000-00-00NoNoCurrent
71335-1572-37133515720390 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1572-3) 2020-04-210000-00-00NoNoCurrent
71335-1572-47133515720456 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1572-4) 2026-05-130000-00-00NoNoCurrent
71335-1572-57133515720528 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1572-5) 2026-05-130000-00-00NoNoCurrent
71335-1572-67133515720610 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1572-6) 2026-05-130000-00-00NoNoCurrent
71335-1572-771335157207120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1572-7) 2026-05-130000-00-00NoNoCurrent
71335-1572-871335157208180 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1572-8) 2020-07-070000-00-00NoNoCurrent
71335-1572-9713351572093 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1572-9) 2026-05-13NoNoHistorical