FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
72162-2503
11-digit product format
721622503
Labeler code
72162
Product ID
72162-2503_a378b7ff-0f7f-48f7-9491-271b6d2e92cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204237
Marketing category
ANDA
Marketing start
2017-06-01
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
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
72162-2503-3RABEPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE302
72162-2503-5RABEPRAZOLE SODIUM500 in 1 BOTTLETABLET, DELAYED RELEASE5002
72162-2503-9RABEPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2503RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 3 package rows20250515_350c20b0-1879-d4cb-e063-6294a90a37f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN350c20b0-1879-d4cb-e063-6294a90a37f22
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD350c20b0-1879-d4cb-e063-6294a90a37f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2503-37216225030330 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2503-3) 2017-06-01NoNoHistorical
72162-2503-572162250305500 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2503-5) 2017-06-01NoNoHistorical
72162-2503-97216225030990 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2503-9) 2017-06-01NoNoHistorical