FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
71335-2304
11-digit product format
713352304
Labeler code
71335
Product ID
71335-2304_1e267239-c875-49db-9900-8f62e6f065ca
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
71335-2304-2RABEPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE90101
71335-2304-3RABEPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE30101
71335-2304-4RABEPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE60101
71335-2304-5RABEPRAZOLE SODIUM28 in 1 BOTTLETABLET, DELAYED RELEASE28101
71335-2304-6RABEPRAZOLE SODIUM120 in 1 BOTTLETABLET, DELAYED RELEASE120101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2304-3EA - Each71335-23040a2996db-51b5-4136-9465-28e6fc4039ac12024-01-04
71335-2304-4EA - Each71335-23047506bc9d-8495-4e67-8e6e-46d23aba843812024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2304RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 5 package rows20231212_4e8b9858-23a1-4363-b26f-ee6b9ff7ebf9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN4e8b9858-23a1-4363-b26f-ee6b9ff7ebf9101
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD4e8b9858-23a1-4363-b26f-ee6b9ff7ebf9101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2304-27133523040290 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2304-2) 2023-12-08NoNoHistorical
71335-2304-37133523040330 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2304-3) 2023-12-08NoNoHistorical
71335-2304-47133523040460 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2304-4) 2023-12-08NoNoHistorical
71335-2304-57133523040528 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2304-5) 2023-12-08NoNoHistorical
71335-2304-671335230406120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2304-6) 2023-12-08NoNoHistorical