FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
68788-8644
11-digit product format
687888644
Labeler code
68788
Product ID
68788-8644_752724a9-4a89-4f98-9da5-4675b7d269e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202882
Marketing category
ANDA
Marketing start
2024-05-01
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
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 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
68788-8644-1PANTOPRAZOLE SODIUM100 in 1 BOTTLETABLET, DELAYED RELEASE1002
68788-8644-3PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE302
68788-8644-6PANTOPRAZOLE SODIUM60 in 1 CARTONTABLET, DELAYED RELEASE602
68788-8644-8PANTOPRAZOLE SODIUM120 in 1 BOTTLETABLET, DELAYED RELEASE1202
68788-8644-9PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8644-1EA - Each68788-86447295ab0d-d07f-4024-b8d7-4b6f7343b26c12024-06-10
68788-8644-3EA - Each68788-86448b139177-4ed3-484f-8f48-5e2ac5dde19b12024-06-10
68788-8644-6EA - Each68788-86447499e52a-5da3-4bea-bbc0-50fb31f7589412024-06-10
68788-8644-8EA - Each68788-86448b26ef02-6c24-42db-b8b2-f986687925e812024-06-10
68788-8644-9EA - Each68788-86447a1ce8fd-ab3b-4ae5-b71c-b2c07edcbba012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8644PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20240531_5c14e2f3-625d-4089-a404-440b0ecf72e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN5c14e2f3-625d-4089-a404-440b0ecf72e72
314200pantoprazole 40 MG Delayed Release Oral TabletSCD5c14e2f3-625d-4089-a404-440b0ecf72e72
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY5c14e2f3-625d-4089-a404-440b0ecf72e72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8644-168788864401100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-1) 2024-05-01NoNoHistorical
68788-8644-36878886440330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-3) 2024-05-01NoNoHistorical
68788-8644-66878886440660 TABLET, DELAYED RELEASE in 1 CARTON (68788-8644-6) 2024-05-01NoNoHistorical
68788-8644-868788864408120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-8) 2024-05-01NoNoHistorical
68788-8644-96878886440990 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-9) 2024-05-01NoNoHistorical