FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
71335-1100
11-digit product format
713351100
Labeler code
71335
Product ID
71335-1100_7e855400-3992-4a3d-8aaa-2547eadbf0d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-1100-2Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE909
71335-1100-3Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE309
71335-1100-4Rabeprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE609
71335-1100-5Rabeprazole Sodium28 in 1 BOTTLETABLET, DELAYED RELEASE289
71335-1100-6Rabeprazole Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1100-2EA - Each71335-11008d73a8a6-0565-48d6-a18c-f0545d68346c12021-11-09
71335-1100-3EA - Each71335-11003afe43bb-1448-4b42-8fcb-a6dff208b97712019-09-05
71335-1100-4EA - Each71335-110066106c95-b6b2-41c4-b4b6-bc1bbdd93f4612021-11-09
71335-1100-5EA - Each71335-110045d344e7-b00f-4070-bc60-bff4c3c9297612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1100RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 5 package rows20240823_9ea2552c-873c-4ab2-84b0-dd54e84e4eee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN9ea2552c-873c-4ab2-84b0-dd54e84e4eee9
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD9ea2552c-873c-4ab2-84b0-dd54e84e4eee9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1100-27133511000290 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1100-2) 2021-02-170000-00-00NoNoCurrent
71335-1100-37133511000330 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1100-3) 2019-02-080000-00-00NoNoCurrent
71335-1100-47133511000460 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1100-4) 2019-03-070000-00-00NoNoCurrent
71335-1100-57133511000528 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1100-5) 2024-04-020000-00-00NoNoCurrent
71335-1100-671335110006120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1100-6) 2024-04-020000-00-00NoNoCurrent