FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM D/R

Product NDC
61919-700
11-digit product format
619190700
Labeler code
61919
Product ID
61919-700_ea4eba83-bc84-6424-e053-2a95a90ab692
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM D/R
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090074
Marketing category
ANDA
Marketing start
2019-08-28
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
2023-12-31
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
61919-700-302025-01-30C16284748780-12cef2736-74dc-d83d-e063-dadaa90ab31fPANTOPRAZOLE SODIUM D/R
61919-700-402025-01-30C16284748780-12cef2736-7bf6-d83d-e063-dadaa90ab31fPANTOPRAZOLE SODIUM D/R
61919-700-902025-01-30C16284748780-12cef2736-7a87-d83d-e063-dadaa90ab31fPANTOPRAZOLE SODIUM D/R

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-700-30PANTOPRAZOLE SODIUM D/R30 in 1 BOTTLETABLET, DELAYED RELEASE302
61919-700-40PANTOPRAZOLE SODIUM D/R40 in 1 BOTTLETABLET, DELAYED RELEASE402
61919-700-90PANTOPRAZOLE SODIUM D/R90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-700-30EA - Each61919-700573db7ea-44fc-4115-84f5-1db64533780a12019-09-05
61919-700-40EA - Each61919-700304917b2-0454-4dee-a67a-ec97e99a310412019-09-05
61919-700-90EA - Each61919-700e7c5627f-8c28-47f4-ab8e-c00968ec538612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-700PANTOPRAZOLE SODIUM D/R TABLET, DELAYED RELEASE [DIRECT_RX]2Legacy NDC, 1 package rows20221007_913221df-021c-e511-e053-2995a90a4948.zip
61919-700PANTOPRAZOLE SODIUM D/R TABLET, DELAYED RELEASE [DIRECT_RX]2Legacy NDC, 1 package rows20221007_914372d5-3500-4e91-e053-2a95a90a4855.zip
61919-700PANTOPRAZOLE SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1Legacy NDC, 1 package rows20190119_7cc5510a-8777-3878-e053-2a91aa0a5d32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN913221df-021c-e511-e053-2995a90a49482
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN914372d5-3500-4e91-e053-2a95a90a48552
314200pantoprazole 40 MG Delayed Release Oral TabletSCD913221df-021c-e511-e053-2995a90a49482
314200pantoprazole 40 MG Delayed Release Oral TabletSCD914372d5-3500-4e91-e053-2a95a90a48552
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY913221df-021c-e511-e053-2995a90a49482
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY914372d5-3500-4e91-e053-2a95a90a48552
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN7cc5510a-8777-3878-e053-2a91aa0a5d321
314200pantoprazole 40 MG Delayed Release Oral TabletSCD7cc5510a-8777-3878-e053-2a91aa0a5d321
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY7cc5510a-8777-3878-e053-2a91aa0a5d321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-700-306191907003030 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-700-30) 2019-08-290000-00-00NoNoCurrent
61919-700-406191907004040 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-700-40) 2019-08-280000-00-00NoNoCurrent
61919-700-906191907009090 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-700-90) 2018-12-110000-00-00NoNoCurrent