FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
51407-184
11-digit product format
514070184
Labeler code
51407
Product ID
51407-184_163e20cc-f058-9b74-e063-6294a90a0a3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
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
51407-184-05Rabeprazole Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE5009
51407-184-30Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE309
51407-184-90Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-184-05EA - Each51407-184e971c9d9-e574-4d2c-8c33-146b3ef8419712019-06-19
51407-184-30EA - Each51407-1849d9cfa58-0b9f-40b7-a4de-c2e1eeca351b12019-06-19
51407-184-90EA - Each51407-18435c0be24-acb4-46e0-8847-8b08c0810f5112019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-184RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]9Current NDC, Legacy NDC, 3 package rows20240418_87231460-8b1e-b995-e053-2a91aa0a6c43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN87231460-8b1e-b995-e053-2a91aa0a6c439
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD87231460-8b1e-b995-e053-2a91aa0a6c439

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-184-0551407018405500 TABLET, DELAYED RELEASE in 1 BOTTLE (51407-184-05) 2019-04-250000-00-00NoNoCurrent
51407-184-305140701843030 TABLET, DELAYED RELEASE in 1 BOTTLE (51407-184-30) 2019-04-250000-00-00NoNoCurrent
51407-184-905140701849090 TABLET, DELAYED RELEASE in 1 BOTTLE (51407-184-90) 2019-04-250000-00-00NoNoCurrent