FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
71205-292
11-digit product format
712050292
Labeler code
71205
Product ID
71205-292_aaff34d4-40c2-49c9-9ab1-af8182783954
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208644
Marketing category
ANDA
Marketing start
2018-04-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rabeprazole Sodium
Listing expiration
2027-12-31

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
71205-292-03Rabeprazole Sodium3 in 1 BOTTLETABLET, DELAYED RELEASE35
71205-292-30Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE305
71205-292-60Rabeprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE605
71205-292-90Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-292-30EA - Each71205-292e2b6dba6-1b09-4b4d-98b9-bd4c2b4e574712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-292RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20221129_68b7a793-f22b-4609-a640-94fdec703d93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN68b7a793-f22b-4609-a640-94fdec703d935
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD68b7a793-f22b-4609-a640-94fdec703d935

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-292-03712050292033 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-292-03) 2026-05-13NoNoHistorical
71205-292-307120502923030 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-292-30) 2019-07-010000-00-00NoNoCurrent
71205-292-607120502926060 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-292-60) 2019-07-010000-00-00NoNoCurrent
71205-292-907120502929090 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-292-90) 2019-07-010000-00-00NoNoCurrent