FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
71335-0244
11-digit product format
713350244
Labeler code
71335
Product ID
71335-0244_99bc4d0e-37f0-4be4-a7c9-4f9cc083ae7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090678
Marketing category
ANDA
Marketing start
2013-11-08
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
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0244-2Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9011
71335-0244-3Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3011
71335-0244-4Rabeprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE6011
71335-0244-5Rabeprazole Sodium28 in 1 BOTTLETABLET, DELAYED RELEASE2811
71335-0244-6Rabeprazole Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE12011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0244-2EA - Each71335-024468172964-0e7b-42e0-9032-af9ccc7b4b3012018-01-12
71335-0244-3EA - Each71335-0244b3c0ebe9-725f-465f-b77b-5c890e44c3e212018-01-12
71335-0244-4EA - Each71335-0244b62dd525-a861-4996-96ac-c3cec6750f1e12018-01-12
71335-0244-5EA - Each71335-0244a2223416-56c3-474b-b3c0-05e24f773c6212018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0244RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 5 package rows20231205_e6350638-99b0-474d-be75-ae2a3e1af2cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNe6350638-99b0-474d-be75-ae2a3e1af2cf11
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDe6350638-99b0-474d-be75-ae2a3e1af2cf11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0244-27133502440290 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0244-2) 2021-04-010000-00-00NoNoCurrent
71335-0244-37133502440330 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0244-3) 2018-06-210000-00-00NoNoCurrent
71335-0244-47133502440460 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0244-4) 2018-06-190000-00-00NoNoCurrent
71335-0244-57133502440528 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0244-5) 2022-05-020000-00-00NoNoCurrent
71335-0244-671335024406120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0244-6) 2022-05-020000-00-00NoNoCurrent