FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
65862-721
11-digit product format
658620721
Labeler code
65862
Product ID
65862-721_3a12547f-7c57-44f8-a6bb-d3287701033f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA205761
Marketing category
ANDA
Marketing start
2017-02-17
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
65862-721-30Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE308
65862-721-90Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-721-30EA - Each65862-7216064ff2e-b4e5-4ea7-aaac-f7c922e32ce812019-03-12
65862-721-90EA - Each65862-7215ea90938-aa92-4722-8cda-530545ff2e1912019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-721RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 2 package rows20240301_d11c3211-b4d4-4893-8c1c-b8fb6d0a0b89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNb1b7def0-834f-37f5-e053-2a95a90ade1f8
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNd11c3211-b4d4-4893-8c1c-b8fb6d0a0b898
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb1b7def0-834f-37f5-e053-2a95a90ade1f8
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDd11c3211-b4d4-4893-8c1c-b8fb6d0a0b898
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNb35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf4
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf4
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN12eaf996-db61-41d6-82e1-fa61964356031
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD12eaf996-db61-41d6-82e1-fa61964356031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-721-306586207213030 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-721-30) 2017-02-170000-00-00NoNoCurrent
65862-721-906586207219090 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-721-90) 2017-02-170000-00-00NoNoCurrent