FDA.reportPublic FDA data

Pantoprazole sodium delayed-release

Product NDC
70756-018
11-digit product format
707560018
Labeler code
70756
Product ID
70756-018_2c507c43-c033-4b6e-b954-f0f2fb617289
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole sodium delayed-release
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA215880
Marketing category
ANDA
Marketing start
2024-04-25
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 delayed-release
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-018-51Pantoprazole sodium delayed-release500 in 1 BOTTLETABLET50011
70756-018-90Pantoprazole sodium delayed-release90 in 1 BOTTLETABLET9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-018PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLET [LIFESTAR PHARMA LLC]10Current NDC, 2 package rows20240503_0502f935-af7a-4f1e-8c3e-29e20647c885.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN0502f935-af7a-4f1e-8c3e-29e20647c88511
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN0502f935-af7a-4f1e-8c3e-29e20647c88511
251872pantoprazole 20 MG Delayed Release Oral TabletSCD0502f935-af7a-4f1e-8c3e-29e20647c88511
314200pantoprazole 40 MG Delayed Release Oral TabletSCD0502f935-af7a-4f1e-8c3e-29e20647c88511
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY0502f935-af7a-4f1e-8c3e-29e20647c88511
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY0502f935-af7a-4f1e-8c3e-29e20647c88511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-018-5170756001851500 TABLET in 1 BOTTLE (70756-018-51) 500 tablet2024-04-25NoNoHistorical
70756-018-907075600189090 TABLET in 1 BOTTLE (70756-018-90) 90 tablet2024-04-25NoNoHistorical