FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
50090-6887
11-digit product format
500906887
Labeler code
50090
Product ID
50090-6887_2fb92517-ad93-4385-aadc-33ce1b770a25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-6887-0RABEPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE301
50090-6887-1RABEPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6887-0EA - Each50090-68872d004c57-aa50-497a-acd8-349aa338d20512024-01-04
50090-6887-1EA - Each50090-6887c3bd9469-efa4-40c3-bd9c-4eff5f84115212024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6887RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20231212_bafff1ac-02fb-4726-b2d7-6e099ae981cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNbafff1ac-02fb-4726-b2d7-6e099ae981cb1
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDbafff1ac-02fb-4726-b2d7-6e099ae981cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6887-05009068870030 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-6887-0) 2023-12-06NoNoCurrent
50090-6887-15009068870190 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-6887-1) 2023-12-06NoNoCurrent