FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
70518-1298
11-digit product format
705181298
Labeler code
70518
Product ID
70518-1298_51015a6f-c84e-ecd9-e063-6294a90a76b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202038
Marketing category
ANDA
Marketing start
2018-07-12
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
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 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
70518-1298-0Pantoprazole Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE3023
70518-1298-1Pantoprazole Sodium100 in 1 BOXTABLET, DELAYED RELEASE10023
70518-1298-2Pantoprazole Sodium1 in 1 POUCHTABLET, DELAYED RELEASE123
70518-1298-3Pantoprazole Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE3023
70518-1298-4Pantoprazole Sodium90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE9023
70518-1298-5Pantoprazole Sodium28 in 1 BLISTER PACKTABLET, DELAYED RELEASE2823
70518-1298-6Pantoprazole Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3023
70518-1298-7Pantoprazole Sodium14 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1423
70518-1298-8Pantoprazole Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1298PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.]17Current NDC, Legacy NDC, 9 package rows20250507_f38a6df2-1dd4-48bf-9ec4-1113ce492e78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNf38a6df2-1dd4-48bf-9ec4-1113ce492e7823
314200pantoprazole 40 MG Delayed Release Oral TabletSCDf38a6df2-1dd4-48bf-9ec4-1113ce492e7823
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYf38a6df2-1dd4-48bf-9ec4-1113ce492e7823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1298-07051812980030 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-1298-0) 2018-07-12NoNoCurrent
70518-1298-170518129801100 POUCH in 1 BOX (70518-1298-1) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-1298-2) 100 pouch2021-08-030000-00-00NoNoCurrent
70518-1298-2705181298021 in 1 POUCHHistorical
70518-1298-37051812980330 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-1298-3) 2021-10-140000-00-00NoNoCurrent
70518-1298-47051812980490 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1298-4) 2022-03-080000-00-00NoNoCurrent
70518-1298-57051812980528 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-1298-5) 2022-05-150000-00-00NoNoCurrent
70518-1298-67051812980630 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-1298-6) 2022-06-050000-00-00NoNoCurrent
70518-1298-77051812980714 in 1 BOTTLE, PLASTICHistorical
70518-1298-87051812980830 in 1 BOTTLE, PLASTICHistorical