FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
80425-0094
11-digit product format
804250094
Labeler code
80425
Product ID
80425-0094_4ceff784-d22b-ca0b-e063-6294a90aa061
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx 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
80425-0094-1Rabeprazole SodiumDR30 in 1 BOTTLETABLET, DELAYED RELEASE3010
80425-0094-2Rabeprazole SodiumDR60 in 1 BOTTLETABLET, DELAYED RELEASE6010
80425-0094-3Rabeprazole SodiumDR6 in 1 BOTTLETABLET, DELAYED RELEASE610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0094-1EA - Each80425-0094585068be-4e35-401f-9d08-9941fe34775a12023-03-13
80425-0094-2EA - Each80425-009457c01e6d-f304-4229-8ab1-6d7175f6212412023-03-13
80425-0094-3EA - Each80425-0094242448a5-c1b8-4b58-a525-68a369e00bff12026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0094RABEPRAZOLE SODIUM DR (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 3 package rows20250101_b354053c-cb83-79c6-e053-2a95a90afdbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNb354053c-cb83-79c6-e053-2a95a90afdbe10
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb354053c-cb83-79c6-e053-2a95a90afdbe10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0094-18042500940130 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0094-1) 2018-04-270000-00-00NoNoCurrent
80425-0094-28042500940260 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0094-2) 2018-04-270000-00-00NoNoCurrent
80425-0094-3804250094036 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0094-3) 2018-04-27NoNoHistorical