PANTOPRAZOLE SODIUM

Product NDC
61919-806
11-digit product format
619190806
Labeler code
61919
Product ID
61919-806_94e52165-e8e5-a353-e053-2995a90ab296
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090074
Marketing category
ANDA
Marketing start
2019-05-01
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
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-806-302023-01-30C16284748780-1f386c64a-383c-0266-e053-dadaa90a7c1aPANTOPRAZOLE SODIUM
61919-806-602023-01-30C16284748780-1f386c64a-383c-0266-e053-dadaa90a7c1aPANTOPRAZOLE SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-806-30PANTOPRAZOLE SODIUMDR30 in 1 BOTTLETABLET, DELAYED RELEASE303
61919-806-60PANTOPRAZOLE SODIUMDR60 in 1 BOTTLETABLET, DELAYED RELEASE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-806PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE PANTOPRAZOLE SODIUM DR (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [DIRECT RX]3Legacy NDC, 2 package rows20191015_491102c1-f04b-4b7b-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN491102c1-f04b-4b7b-e054-00144ff8d46c3
251872pantoprazole 20 MG Delayed Release Oral TabletSCD491102c1-f04b-4b7b-e054-00144ff8d46c3
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY491102c1-f04b-4b7b-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-806-306191908063030 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-806-30) 2019-05-020000-00-00NoNoCurrent
61919-806-606191908066060 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-806-60) 2019-05-010000-00-00NoNoCurrent