FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
71205-603
11-digit product format
712050603
Labeler code
71205
Product ID
71205-603_ddba7982-5cbb-4a0f-9425-542cb118e9fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
71205-603-30RABEPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE302
71205-603-60RABEPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE602
71205-603-90RABEPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-603-30EA - Each71205-603ded139df-77db-46e0-ab41-7d7d85c1727112021-12-08
71205-603-60EA - Each71205-60314f01c4c-6813-4c20-8771-8e6cac53999d12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-603RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220426_0f5eb1b4-ad4b-4782-8d3d-cd33f9c5be7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN0f5eb1b4-ad4b-4782-8d3d-cd33f9c5be7d2
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD0f5eb1b4-ad4b-4782-8d3d-cd33f9c5be7d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-603-307120506033030 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-603-30) 2021-09-140000-00-00NoNoCurrent
71205-603-607120506036060 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-603-60) 2021-09-140000-00-00NoNoCurrent
71205-603-907120506039090 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-603-90) 2021-09-140000-00-00NoNoCurrent