FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
80425-0363
11-digit product format
804250363
Labeler code
80425
Product ID
80425-0363_2a998081-6423-8228-e063-6294a90adc3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA204237
Marketing category
ANDA
Marketing start
2023-10-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RABEPRAZOLE SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RABEPRAZOLE SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3L36P16U4R
Rxcui854868

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0363-1RABEPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE302
80425-0363-2RABEPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE602
80425-0363-3RABEPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0363-1EA - Each80425-0363144fd34a-43fb-427c-8f8b-46bfe2b77fea12023-12-05
80425-0363-2EA - Each80425-0363dee3dc6c-a69c-4eeb-bdc4-d6960bef498912023-12-05
80425-0363-3EA - Each80425-0363e3cfcd29-0d85-4fd1-8476-33a4271a6d0b12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0363RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 3 package rows20250101_0863f340-4c7e-379a-e063-6394a90a758d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN0863f340-4c7e-379a-e063-6394a90a758d2
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD0863f340-4c7e-379a-e063-6394a90a758d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0363-18042503630130 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0363-1) 2023-10-23NoNoHistorical
80425-0363-28042503630260 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0363-2) 2023-10-23NoNoHistorical
80425-0363-38042503630390 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0363-3) 2023-10-23NoNoHistorical