Pantoprazole Sodium

Product NDC
72603-746
11-digit product format
726030746
Labeler code
72603
Product ID
72603-746_6637d90b-b268-4a5f-ab5b-885f2d5f0d4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA202038
Marketing category
ANDA
Marketing start
2026-03-01
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
72603-746-01Pantoprazole Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE5001
72603-746-02Pantoprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-746-01EA - Each72603-746fb4d2b2f-02bd-47f6-8a04-d7d686c3105412026-05-22
72603-746-02EA - Each72603-7460ae3b6fc-31fa-4c13-9ca2-70601c6b654312026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN6637d90b-b268-4a5f-ab5b-885f2d5f0d4b1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD6637d90b-b268-4a5f-ab5b-885f2d5f0d4b1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY6637d90b-b268-4a5f-ab5b-885f2d5f0d4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-746-0172603074601500 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-746-01) 2026-03-01NoNoCurrent
72603-746-02726030746021000 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-746-02) 2026-03-01NoNoCurrent