FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
0904-6474
11-digit product format
009046474
Labeler code
0904
Product ID
0904-6474_349f9634-a35a-487f-acec-9148dba002cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090074
Marketing category
ANDA
Marketing start
2015-06-01
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
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 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
0904-6474-06Pantoprazole Sodium50 in 1 CARTONTABLET, DELAYED RELEASE509
0904-6474-06Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE19
0904-6474-45Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE19
0904-6474-45Pantoprazole Sodium80 in 1 CARTONTABLET, DELAYED RELEASE809
0904-6474-61Pantoprazole Sodium100 in 1 CARTONTABLET, DELAYED RELEASE1009
0904-6474-61Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6474PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 6 package rows20241109_9c286e5c-2b36-422b-9f74-e8c0abb3f747.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN6b5ed424-2203-482f-bb85-2c97d9c356f214
314200pantoprazole 40 MG Delayed Release Oral TabletSCD6b5ed424-2203-482f-bb85-2c97d9c356f214
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY6b5ed424-2203-482f-bb85-2c97d9c356f214
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN9c286e5c-2b36-422b-9f74-e8c0abb3f7479
314200pantoprazole 40 MG Delayed Release Oral TabletSCD9c286e5c-2b36-422b-9f74-e8c0abb3f7479
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY9c286e5c-2b36-422b-9f74-e8c0abb3f7479

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6474-060090464740650 BLISTER PACK in 1 CARTON (0904-6474-06) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK50 blister pack2026-02-12NoNoCurrent
0904-6474-450090464744580 BLISTER PACK in 1 CARTON (0904-6474-45) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK80 blister pack2015-06-012023-08-31NoNoCurrent
0904-6474-6100904647461100 BLISTER PACK in 1 CARTON (0904-6474-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2015-06-010000-00-00NoNoCurrent