FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
64980-676
11-digit product format
649800676
Labeler code
64980
Product ID
64980-676_9fe81197-8014-4967-aa15-7525509d532c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA219087
Marketing category
ANDA
Marketing start
2025-03-12
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 SODIUM
Listing expiration
2026-12-31

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
64980-676-09PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-676-09EA - Each64980-67690f2ef17-9edc-4997-aad5-ba4d541ce16212025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-676PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]2Current NDC, 1 package rows20250515_91a6b13f-457f-4136-9541-c4adb9c3c35c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN91a6b13f-457f-4136-9541-c4adb9c3c35c2
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN91a6b13f-457f-4136-9541-c4adb9c3c35c2
251872pantoprazole 20 MG Delayed Release Oral TabletSCD91a6b13f-457f-4136-9541-c4adb9c3c35c2
314200pantoprazole 40 MG Delayed Release Oral TabletSCD91a6b13f-457f-4136-9541-c4adb9c3c35c2
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY91a6b13f-457f-4136-9541-c4adb9c3c35c2
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY91a6b13f-457f-4136-9541-c4adb9c3c35c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64980-676-096498006760990 TABLET, DELAYED RELEASE in 1 BOTTLE (64980-676-09) 2025-03-12NoNoHistorical