FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
45865-676
11-digit product format
458650676
Labeler code
45865
Product ID
45865-676_9adc585b-0718-4980-e053-2a95a90afebb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA205119
Marketing category
ANDA
Marketing start
2016-06-20
Marketing end
0000-00-00
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
2020-12-31
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
45865-676-302025-01-30C16284748780-12cef2736-6a4f-d83d-e063-dadaa90ab31fThese 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
45865-676-30Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-676PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191230_9adbe021-4638-934d-e053-2995a90a5ae9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN9adbe021-4638-934d-e053-2995a90a5ae91
314200pantoprazole 40 MG Delayed Release Oral TabletSCD9adbe021-4638-934d-e053-2995a90a5ae91
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY9adbe021-4638-934d-e053-2995a90a5ae91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-676-304586506763030 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-676-30) 2018-12-120000-00-00NoNoCurrent