FDA.reportPublic FDA data

RABERPRAZOLE SODIUM D/R

Product NDC
61919-225
11-digit product format
619190225
Labeler code
61919
Product ID
61919-225_e99adbfd-c37a-0521-e053-2a95a90afba1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RABERPRAZOLE SODIUM D/R
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA202376
Marketing category
ANDA
Marketing start
2019-08-07
Marketing end
0000-00-00
Substance
RABEPRAZOLE SODIUM
Active strength
20 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-225-602025-01-30C16284748780-12cef2736-84fe-d83d-e063-dadaa90ab31fRABERPRAZOLE SODIUM D/R 20mg
61919-225-902025-01-30C16284748780-12cef2736-84fe-d83d-e063-dadaa90ab31fRABERPRAZOLE SODIUM D/R 20mg
61919-225-302021-01-07C16284748780-19d75b9d0-b89f-f424-e053-dadaa90a57ce5cc620a3-2d65-1ccf-e053-2a91aa0a1a91
61919-225-302020-01-31C16284748780-19d75b9d0-b89f-f424-e053-dadaa90a57ce5cc620a3-2d65-1ccf-e053-2a91aa0a1a91

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-225-60RABERPRAZOLE SODIUM D/R60 in 1 BOTTLETABLET, DELAYED RELEASE606
61919-225-90RABERPRAZOLE SODIUM D/R90 in 1 BOTTLETABLET, DELAYED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-225-30EA - Each61919-2251e512ff7-241c-48d0-994d-42601d0bc68412019-08-06
61919-225-60EA - Each61919-225a3db4787-459b-4d9d-9e69-d7436b06403512019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-225RABERPRAZOLE SODIUM D/R TABLET, DELAYED RELEASE [DIRECT_RX]6Legacy NDC, 2 package rows20230415_8f896469-4df5-599c-e053-2a95a90ac924.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN8f896469-4df5-599c-e053-2a95a90ac9246
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD8f896469-4df5-599c-e053-2a95a90ac9246

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-225-306191902253030 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-225-30) 2017-10-300000-00-00NoNoCurrent
61919-225-606191902256060 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-225-60) 2019-08-070000-00-00NoNoCurrent
61919-225-906191902259090 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-225-90) 2019-08-070000-00-00NoNoCurrent