FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
45865-130
11-digit product format
458650130
Labeler code
45865
Product ID
45865-130_b0f41131-8792-7e53-e053-2a95a90a5fb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA202882
Marketing category
ANDA
Marketing start
2014-09-10
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-130-602023-01-30C16284748780-1f386c64a-4857-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-130-60PANTOPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-130PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20201006_b0f40e59-37ce-df8b-e053-2995a90a01ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNb0f40e59-37ce-df8b-e053-2995a90a01ce1
251872pantoprazole 20 MG Delayed Release Oral TabletSCDb0f40e59-37ce-df8b-e053-2995a90a01ce1
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYb0f40e59-37ce-df8b-e053-2995a90a01ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-130-604586501306060 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-130-60) 2018-07-060000-00-00NoNoCurrent