FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
62135-503
11-digit product format
621350503
Labeler code
62135
Product ID
62135-503_45adfadd-b711-a916-e063-6394a90ac34c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC
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
62135-503-30Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE302
62135-503-90Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-503-30EA - Each62135-503f93c9a8c-f0f8-4109-8f6c-28048113f0bd12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-503RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [CHARTWELL RX, LLC]1Current NDC, 2 package rows20230504_c5c43222-d167-4152-b5c7-84b55920a7ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNc5c43222-d167-4152-b5c7-84b55920a7ce2
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDc5c43222-d167-4152-b5c7-84b55920a7ce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-503-306213505033030 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-503-30) 2023-04-27NoNoCurrent
62135-503-906213505039090 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-503-90) 2023-04-27NoNoCurrent