FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
70518-3209
11-digit product format
705183209
Labeler code
70518
Product ID
70518-3209_4eceae9b-2aa9-b3b9-e063-6394a90ac32a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204237
Marketing category
ANDA
Marketing start
2021-09-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RABEPRAZOLE SODIUM
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
70518-3209-0RABEPRAZOLE SODIUM60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE607
70518-3209-1RABEPRAZOLE SODIUM30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3209-0EA - Each70518-3209b2c4082b-7e41-4cc3-9a3d-9b808614e5d612023-01-09
70518-3209-1EA - Each70518-320942927cef-78d3-47ae-a7e6-1766831ddb2e12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3209RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 2 package rows20240315_0e2e00fa-c4c5-4de7-adf9-cd9786b97016.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN0e2e00fa-c4c5-4de7-adf9-cd9786b970167
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD0e2e00fa-c4c5-4de7-adf9-cd9786b970167

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3209-07051832090060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3209-0) 2021-09-010000-00-00NoNoCurrent
70518-3209-17051832090130 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3209-1) 2021-09-210000-00-00NoNoCurrent