FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
76420-107
11-digit product format
764200107
Labeler code
76420
Product ID
76420-107_a8f5a654-c183-044b-e053-2995a90af261
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA205761
Marketing category
ANDA
Marketing start
2017-02-17
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
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
76420-107-30Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301
76420-107-60Rabeprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE601
76420-107-90Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-107-60EA - Each76420-10735dbd013-5b7f-4dcd-90a9-6a4c91493ab412021-01-08
76420-107-90EA - Each76420-107836a457b-ef80-422a-a443-2fde2c5b555512021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-107RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 3 package rows20200627_12eaf996-db61-41d6-82e1-fa6196435603.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN12eaf996-db61-41d6-82e1-fa61964356031
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD12eaf996-db61-41d6-82e1-fa61964356031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-107-307642001073030 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-107-30) 2020-06-260000-00-00NoNoCurrent
76420-107-607642001076060 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-107-60) 2020-06-260000-00-00NoNoCurrent
76420-107-907642001079090 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-107-90) 2020-06-260000-00-00NoNoCurrent