FDA.reportPublic FDA data

Pantoprazole

Product NDC
68788-8505
11-digit product format
687888505
Labeler code
68788
Product ID
68788-8505_3b11bd25-3420-4257-b821-d3fc79ef7fc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077619
Marketing category
ANDA
Marketing start
2023-08-15
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
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
68788-8505-1Pantoprazole100 in 1 BOTTLETABLET, DELAYED RELEASE1003
68788-8505-3Pantoprazole30 in 1 BOTTLETABLET, DELAYED RELEASE303
68788-8505-6Pantoprazole60 in 1 BOTTLETABLET, DELAYED RELEASE603
68788-8505-8Pantoprazole120 in 1 BOTTLETABLET, DELAYED RELEASE1203
68788-8505-9Pantoprazole90 in 1 BOTTLETABLET, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8505-1EA - Each68788-850542d01955-cca6-4c59-9693-719e26f9b28f12023-10-16
68788-8505-3EA - Each68788-850546f4a115-b006-4899-a664-b99a5b5c717212023-10-16
68788-8505-6EA - Each68788-85050f7b14df-bd89-4630-b6b9-ce32609d7c8912023-10-16
68788-8505-8EA - Each68788-85056fe962e8-6c61-45cf-9837-cdff0a4170ee12023-10-16
68788-8505-9EA - Each68788-85054de8d04a-ab91-48ea-9777-2b34b3620bc812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8505PANTOPRAZOLE TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20240727_bb1e79ad-ff52-4696-8743-523f793b29d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNbb1e79ad-ff52-4696-8743-523f793b29d33
251872pantoprazole 20 MG Delayed Release Oral TabletSCDbb1e79ad-ff52-4696-8743-523f793b29d33
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYbb1e79ad-ff52-4696-8743-523f793b29d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8505-168788850501100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-1) 2023-08-15NoNoHistorical
68788-8505-36878885050330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-3) 2023-08-15NoNoHistorical
68788-8505-66878885050660 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-6) 2023-08-15NoNoHistorical
68788-8505-868788850508120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-8) 2023-08-15NoNoHistorical
68788-8505-96878885050990 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-9) 2023-08-15NoNoHistorical