FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
62175-618
11-digit product format
621750618
Labeler code
62175
Product ID
62175-618_cfbf12d8-f656-4b99-bd2e-fb11bab669e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA078281
Marketing category
ANDA
Marketing start
2011-01-20
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, 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
62175-618-43Pantoprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100057
62175-618-46Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9057

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-618PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LANNETT COMPANY, INC.]57Current NDC, Legacy NDC, 2 package rows20230819_e7705bf6-e473-4b9c-bb5d-57e26ffe7b97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
251872pantoprazole 20 MG Delayed Release Oral TabletSCDe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
314200pantoprazole 40 MG Delayed Release Oral TabletSCDe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNd6aae78e-308b-7072-e053-2a95a90aaa104
251872pantoprazole 20 MG Delayed Release Oral TabletSCDd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole 40 MG Delayed Release Oral TabletSCDd6aae78e-308b-7072-e053-2a95a90aaa104
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYd6aae78e-308b-7072-e053-2a95a90aaa104
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNb9fa8381-b75e-b1cd-e053-2a95a90a98833
251872pantoprazole 20 MG Delayed Release Oral TabletSCDb9fa8381-b75e-b1cd-e053-2a95a90a98833
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYb9fa8381-b75e-b1cd-e053-2a95a90a98833

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-618-43621750618431000 TABLET, DELAYED RELEASE in 1 BOTTLE (62175-618-43) 2011-01-200000-00-00NoNoCurrent
62175-618-466217506184690 TABLET, DELAYED RELEASE in 1 BOTTLE (62175-618-46) 2011-01-200000-00-00NoNoCurrent