FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
68788-7459
11-digit product format
687887459
Labeler code
68788
Product ID
68788-7459_20aadee0-d25c-4e62-b543-62b344a2fbdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
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
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
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
68788-7459-3Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE307
68788-7459-6Rabeprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7459-3EA - Each68788-7459770e727b-89e1-47b3-ae74-c512092b5d7412020-09-14
68788-7459-6EA - Each68788-74595242d82e-d811-4dac-9023-b59cf2dc2d2a12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7459RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20240806_ac9266ed-a9b2-4e77-8607-393b5dcdd2b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNac9266ed-a9b2-4e77-8607-393b5dcdd2b67
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDac9266ed-a9b2-4e77-8607-393b5dcdd2b67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7459-36878874590330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-7459-3) 2019-12-270000-00-00NoNoCurrent
68788-7459-66878874590660 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-7459-6) 2019-12-270000-00-00NoNoCurrent