FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
76420-818
11-digit product format
764200818
Labeler code
76420
Product ID
76420-818_4ad5e40b-0272-c104-e063-6294a90a8237
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
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
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
76420-818-30Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE302
76420-818-60Rabeprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE602
76420-818-90Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-818-30EA - Each76420-818a1371133-c4a5-49e6-a39a-b31f3aa7827012024-08-12
76420-818-60EA - Each76420-818f1ce3056-6e41-4ff2-bbbb-d972f9dbc31f12024-08-12
76420-818-90EA - Each76420-81891c9fd30-5b6a-479c-8fb9-da99f6e6809c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-818RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ASCLEMED USA, INC.]1Current NDC, 3 package rows20240626_3b6a25c2-fb61-4c86-9988-c6ffac7939c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN3b6a25c2-fb61-4c86-9988-c6ffac7939c42
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD3b6a25c2-fb61-4c86-9988-c6ffac7939c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-818-307642008183030 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-30) 2024-06-25NoNoHistorical
76420-818-607642008186060 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-60) 2024-06-25NoNoHistorical
76420-818-907642008189090 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-90) 2024-06-25NoNoHistorical