FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
80425-0134
11-digit product format
804250134
Labeler code
80425
Product ID
80425-0134_4df0b57a-090c-2350-e063-6394a90addbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA208644
Marketing category
ANDA
Marketing start
2018-04-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rabeprazole Sodium
Brand name suffix
DR
Listing expiration
2027-12-31

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
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0134-1Rabeprazole SodiumDR30 in 1 BOTTLETABLET, DELAYED RELEASE309
80425-0134-2Rabeprazole SodiumDR60 in 1 BOTTLETABLET, DELAYED RELEASE609
80425-0134-3Rabeprazole SodiumDR90 in 1 BOTTLETABLET, DELAYED RELEASE909
80425-0134-4Rabeprazole SodiumDR6 in 1 BOTTLETABLET, DELAYED RELEASE69

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0134-1EA - Each80425-013446a95f21-cdc8-4907-b4ba-c646a92204d712023-03-13
80425-0134-2EA - Each80425-0134e46ac006-dd6d-4ebe-b3e2-eb28e82a058412023-03-13
80425-0134-3EA - Each80425-013473fa05d4-1265-40c0-85db-99022dc6088512023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0134RABEPRAZOLE SODIUM DR (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 4 package rows20250101_bdad0b58-495e-2352-e053-2a95a90a3198.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNbdad0b58-495e-2352-e053-2a95a90a31989
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDbdad0b58-495e-2352-e053-2a95a90a31989

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0134-18042501340130 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0134-1) 2018-04-270000-00-00NoNoCurrent
80425-0134-28042501340260 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0134-2) 2018-04-270000-00-00NoNoCurrent
80425-0134-38042501340390 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0134-3) 2023-04-28NoNoHistorical
80425-0134-4804250134046 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0134-4) 2026-03-26NoNoHistorical