FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
70518-2590
11-digit product format
705182590
Labeler code
70518
Product ID
70518-2590_4a69aa10-6b5b-07b3-e063-6294a90a7b87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208644
Marketing category
ANDA
Marketing start
2020-02-18
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2590-0Rabeprazole Sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6013
70518-2590-1Rabeprazole Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3013
70518-2590-2Rabeprazole Sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6013
70518-2590-3Rabeprazole Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2590RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 4 package rows20250121_63e0b7ca-6b2d-42a9-b9d4-4523b8a20425.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN63e0b7ca-6b2d-42a9-b9d4-4523b8a2042513
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD63e0b7ca-6b2d-42a9-b9d4-4523b8a2042513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2590-07051825900060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2590-0) 2020-02-180000-00-00NoNoCurrent
70518-2590-17051825900130 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2590-1) 2020-03-250000-00-00NoNoCurrent
70518-2590-27051825900260 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2590-2) 2020-07-160000-00-00NoNoCurrent
70518-2590-37051825900330 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2590-3) 2020-07-310000-00-00NoNoCurrent