FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
76420-674
11-digit product format
764200674
Labeler code
76420
Product ID
76420-674_13ac2fea-63be-66a4-e063-6394a90a7b6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA202882
Marketing category
ANDA
Marketing start
2014-09-10
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
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
76420-674-01PANTOPRAZOLE SODIUM100 in 1 BOTTLETABLET, DELAYED RELEASE1001
76420-674-10PANTOPRAZOLE SODIUM10 in 1 BOTTLETABLET, DELAYED RELEASE101
76420-674-30PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE301
76420-674-60PANTOPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE601
76420-674-90PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-674PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [ASCLEMED USA, INC.]1Current NDC, 5 package rows20240316_3540d01c-da0e-477e-9e90-994b96deb1d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN3540d01c-da0e-477e-9e90-994b96deb1d61
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN3540d01c-da0e-477e-9e90-994b96deb1d61
251872pantoprazole 20 MG Delayed Release Oral TabletSCD3540d01c-da0e-477e-9e90-994b96deb1d61
314200pantoprazole 40 MG Delayed Release Oral TabletSCD3540d01c-da0e-477e-9e90-994b96deb1d61
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY3540d01c-da0e-477e-9e90-994b96deb1d61
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY3540d01c-da0e-477e-9e90-994b96deb1d61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-674-0176420067401100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-674-01) 2024-03-13NoNoHistorical
76420-674-107642006741010 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-674-10) 2024-03-13NoNoHistorical
76420-674-307642006743030 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-674-30) 2024-03-13NoNoHistorical
76420-674-607642006746060 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-674-60) 2024-03-13NoNoHistorical
76420-674-907642006749090 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-674-90) 2024-03-13NoNoHistorical