FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
71610-659
11-digit product format
716100659
Labeler code
71610
Product ID
71610-659_269544ac-1dea-4047-87e6-6e04ff951b55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202882
Marketing category
ANDA
Marketing start
2022-05-01
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
71610-659-09PANTOPRAZOLE SODIUM9000 in 1 BOTTLETABLET, DELAYED RELEASE90002
71610-659-42PANTOPRAZOLE SODIUM1800 in 1 BOTTLETABLET, DELAYED RELEASE18002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-659-09EA - Each71610-659e7ed06cd-8b9d-47f7-9e7f-5951e010af7712022-10-06
71610-659-42EA - Each71610-6594d2aed15-a0f4-4f31-b099-6c73437e452212024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-659PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20230219_c10e9c12-e39d-4b0b-bd4c-10d3e9a4cf34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNc10e9c12-e39d-4b0b-bd4c-10d3e9a4cf342
251872pantoprazole 20 MG Delayed Release Oral TabletSCDc10e9c12-e39d-4b0b-bd4c-10d3e9a4cf342
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYc10e9c12-e39d-4b0b-bd4c-10d3e9a4cf342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-659-09716100659099000 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-659-09) 2022-08-250000-00-00NoNoCurrent
71610-659-42716100659421800 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-659-42) 2023-02-17NoNoCurrent