PANTOPRAZOLE SODIUM

Product NDC
71335-0551
11-digit product format
713350551
Labeler code
71335
Product ID
71335-0551_9bbd7c7e-79e2-476c-83d6-eec38a53fb63
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
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
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
71335-0551-1PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE9015
71335-0551-2PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE3015
71335-0551-3PANTOPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE6015
71335-0551-4PANTOPRAZOLE SODIUM58 in 1 BOTTLETABLET, DELAYED RELEASE5815
71335-0551-5PANTOPRAZOLE SODIUM14 in 1 BOTTLETABLET, DELAYED RELEASE1415
71335-0551-6PANTOPRAZOLE SODIUM100 in 1 BOTTLETABLET, DELAYED RELEASE10015
71335-0551-7PANTOPRAZOLE SODIUM10 in 1 BOTTLETABLET, DELAYED RELEASE1015
71335-0551-8PANTOPRAZOLE SODIUM120 in 1 BOTTLETABLET, DELAYED RELEASE12015
71335-0551-9PANTOPRAZOLE SODIUM180 in 1 BOTTLETABLET, DELAYED RELEASE18015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0551-2EA - Each71335-05519c8eb975-597c-42ed-bb27-2082645ad03a12023-12-05
71335-0551-3EA - Each71335-0551fc955c65-ea83-4e6c-b237-a4215269f63812023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0551PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]15Current NDC, Legacy NDC, 9 package rows20240821_617bb464-5357-472f-8e9d-61aae5b2ebef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN617bb464-5357-472f-8e9d-61aae5b2ebef15
314200pantoprazole 40 MG Delayed Release Oral TabletSCD617bb464-5357-472f-8e9d-61aae5b2ebef15
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY617bb464-5357-472f-8e9d-61aae5b2ebef15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0551-17133505510190 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-1) 2020-09-150000-00-00NoNoCurrent
71335-0551-27133505510230 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-2) 2020-07-310000-00-00NoNoCurrent
71335-0551-37133505510360 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-3) 2020-06-170000-00-00NoNoCurrent
71335-0551-47133505510458 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-4) 2024-04-030000-00-00NoNoCurrent
71335-0551-57133505510514 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-5) 2022-03-100000-00-00NoNoCurrent
71335-0551-671335055106100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-6) 2024-04-030000-00-00NoNoCurrent
71335-0551-77133505510710 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-7) 2024-04-030000-00-00NoNoCurrent
71335-0551-871335055108120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-8) 2024-04-030000-00-00NoNoCurrent
71335-0551-971335055109180 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0551-9) 2024-04-030000-00-00NoNoCurrent