FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
76420-223
11-digit product format
764200223
Labeler code
76420
Product ID
76420-223_e347fcb2-dbe0-193d-e053-2995a90a4784
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA204237
Marketing category
ANDA
Marketing start
2017-06-01
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
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-223-30RABEPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE301
76420-223-60RABEPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE601
76420-223-90RABEPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-223-30EA - Each76420-2237ce82a96-2647-4290-b6bd-bf53f0175b1f12022-08-04
76420-223-60EA - Each76420-223a0cab7e9-a729-427c-bd3b-ff9f0c90f40912022-08-04
76420-223-90EA - Each76420-223e647b1f5-3ee6-430a-b578-b8e130f3b49d12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-223RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 3 package rows20220710_9881dbb2-1ce2-4737-989f-b26720791ca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN9881dbb2-1ce2-4737-989f-b26720791ca51
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD9881dbb2-1ce2-4737-989f-b26720791ca51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-223-307642002233030 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-223-30) 2022-07-070000-00-00NoNoCurrent
76420-223-607642002236060 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-223-60) 2022-07-070000-00-00NoNoCurrent
76420-223-907642002239090 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-223-90) 2022-07-070000-00-00NoNoCurrent