FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
68788-8536
11-digit product format
687888536
Labeler code
68788
Product ID
68788-8536_7cadd193-627f-46b5-84f0-6d612b572ce5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204237
Marketing category
ANDA
Marketing start
2023-10-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RABEPRAZOLE SODIUM
Listing expiration
2026-12-31

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
68788-8536-3RABEPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE303
68788-8536-6RABEPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8536-3EA - Each68788-8536b231be1d-2d4b-4c5d-8eaa-c7de43e522e612023-12-05
68788-8536-6EA - Each68788-85362a13e9ad-842d-4478-98b6-fc63844d0b7a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8536RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20240806_4582d443-f1be-4f94-85da-49aa603f54e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN4582d443-f1be-4f94-85da-49aa603f54e43
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD4582d443-f1be-4f94-85da-49aa603f54e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8536-36878885360330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8536-3) 2023-10-19NoNoCurrent
68788-8536-66878885360660 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8536-6) 2023-10-19NoNoCurrent