FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
50090-3430
11-digit product format
500903430
Labeler code
50090
Product ID
50090-3430_98585303-4cec-4fd2-82f9-159c2897a2fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RABEPRAZOLE SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204237
Marketing category
ANDA
Marketing start
2017-06-01
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
2021-12-31
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
50090-3430-02023-01-30C16284748780-1f386c64a-156e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
50090-3430-12023-01-30C16284748780-1f386c64a-156e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3430-0Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE302
50090-3430-1Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3430-0EA - Each50090-3430a9b1ded1-44bd-4c1b-b56f-4c720abd4c0212020-03-10
50090-3430-1EA - Each50090-3430fb1842f0-c681-4ec9-9950-28108c89e4c312020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3430RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20200219_c1910485-1954-4fbe-9717-4cb9e6fe84a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNc1910485-1954-4fbe-9717-4cb9e6fe84a22
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDc1910485-1954-4fbe-9717-4cb9e6fe84a22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3430-05009034300030 in 1 BOTTLEHistorical
50090-3430-15009034300190 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-3430-1) 2018-04-060000-00-00NoNoCurrent