FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
71335-0291
11-digit product format
713350291
Labeler code
71335
Product ID
71335-0291_74c908a1-9dbb-430f-adab-49d147c49e19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205119
Marketing category
ANDA
Marketing start
2016-06-20
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
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 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
71335-0291-1Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE6012
71335-0291-2Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3012
71335-0291-3Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9012
71335-0291-4Pantoprazole Sodium56 in 1 BOTTLETABLET, DELAYED RELEASE5612
71335-0291-5Pantoprazole Sodium28 in 1 BOTTLETABLET, DELAYED RELEASE2812
71335-0291-6Pantoprazole Sodium10 in 1 BOTTLETABLET, DELAYED RELEASE1012
71335-0291-7Pantoprazole Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE12012
71335-0291-8Pantoprazole Sodium180 in 1 BOTTLETABLET, DELAYED RELEASE18012
71335-0291-9Pantoprazole Sodium3 in 1 BOTTLETABLET, DELAYED RELEASE312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0291-1EA - Each71335-0291b1a6e0c0-8c48-4993-8559-c5e3b765ac0012024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0291PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 9 package rows20240821_d212e8ec-f7ff-4727-a83e-0edc4ca7e6d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNd212e8ec-f7ff-4727-a83e-0edc4ca7e6d112
251872pantoprazole 20 MG Delayed Release Oral TabletSCDd212e8ec-f7ff-4727-a83e-0edc4ca7e6d112
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYd212e8ec-f7ff-4727-a83e-0edc4ca7e6d112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0291-17133502910160 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0291-1) 2022-04-290000-00-00NoNoCurrent
71335-0291-27133502910230 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0291-2) 2022-05-240000-00-00NoNoCurrent
71335-0291-37133502910390 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0291-3) 2022-06-280000-00-00NoNoCurrent
71335-0291-47133502910456 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0291-4) 2022-06-280000-00-00NoNoCurrent
71335-0291-57133502910528 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0291-5) 2022-06-280000-00-00NoNoCurrent
71335-0291-67133502910610 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0291-6) 2022-06-280000-00-00NoNoCurrent
71335-0291-771335029107120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0291-7) 2022-06-280000-00-00NoNoCurrent
71335-0291-871335029108180 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0291-8) 2022-06-280000-00-00NoNoCurrent
71335-0291-9713350291093 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0291-9) 2022-06-28NoNoCurrent