FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
63187-259
11-digit product format
631870259
Labeler code
63187
Product ID
63187-259_8f8de8a7-8144-4822-a6da-962093dc48c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090678
Marketing category
ANDA
Marketing start
2013-11-08
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
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-259-30Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE305
63187-259-60Rabeprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-259-30EA - Each63187-25940463fa2-0f7a-4870-9b45-611816b5466912015-03-03
63187-259-60EA - Each63187-2592958c04c-1262-4d13-b1e5-4ca3112f14cc12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RABEPRAZOLE SODIUMACTIVE INGREDIENT3L36P16U4RRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
RABEPRAZOLEACTIVE MOIETY32828355LLRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-259RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20240711_14412af6-e99c-4264-bc34-28a6f139f252.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN14412af6-e99c-4264-bc34-28a6f139f2525
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD14412af6-e99c-4264-bc34-28a6f139f2525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-259-306318702593030 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-259-30) 2019-01-010000-00-00NoNoCurrent
63187-259-606318702596060 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-259-60) 2019-01-010000-00-00NoNoCurrent