FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
0904-7458
11-digit product format
009047458
Labeler code
0904
Product ID
0904-7458_7f8bdcaa-2a4b-4ed0-a649-a528b3b278a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA202038
Marketing category
ANDA
Marketing start
2024-10-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium
Listing expiration
2027-12-31

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
0904-7458-61Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE16
0904-7458-61Pantoprazole Sodium100 in 1 CARTONTABLET, DELAYED RELEASE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7458-61EA - Each0904-745884e5bafb-dbe5-4444-900a-d780a27f393812024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7458PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]4Current NDC, 2 package rows20241009_de419aa0-caa9-40fb-bc6d-e341c94273c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN6229247e-ee15-466e-a8ac-adcd646b738d6
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNde419aa0-caa9-40fb-bc6d-e341c94273c76
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN6229247e-ee15-466e-a8ac-adcd646b738d6
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNde419aa0-caa9-40fb-bc6d-e341c94273c76
251872pantoprazole 20 MG Delayed Release Oral TabletSCD6229247e-ee15-466e-a8ac-adcd646b738d6
251872pantoprazole 20 MG Delayed Release Oral TabletSCDde419aa0-caa9-40fb-bc6d-e341c94273c76
314200pantoprazole 40 MG Delayed Release Oral TabletSCD6229247e-ee15-466e-a8ac-adcd646b738d6
314200pantoprazole 40 MG Delayed Release Oral TabletSCDde419aa0-caa9-40fb-bc6d-e341c94273c76
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY6229247e-ee15-466e-a8ac-adcd646b738d6
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYde419aa0-caa9-40fb-bc6d-e341c94273c76
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY6229247e-ee15-466e-a8ac-adcd646b738d6
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYde419aa0-caa9-40fb-bc6d-e341c94273c76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7458-6100904745861100 BLISTER PACK in 1 CARTON (0904-7458-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2024-10-07NoNoCurrent