FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
60760-972
11-digit product format
607600972
Labeler code
60760
Product ID
60760-972_1492dd64-cfcb-96c4-e063-6394a90a087d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA204237
Marketing category
ANDA
Marketing start
2021-05-06
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
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
60760-972-07RABEPRAZOLE SODIUM7 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE72
60760-972-30RABEPRAZOLE SODIUM30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-972-07EA - Each60760-972991cb90c-cbf0-47a3-9055-20fc4fd912c712024-05-16
60760-972-30EA - Each60760-97242841a2c-6bb7-487e-b3e2-5af2049a5a9b12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-972RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 2 package rows20240328_c212c9d5-32d3-3c5f-e053-2a95a90af88b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNc212c9d5-32d3-3c5f-e053-2a95a90af88b2
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDc212c9d5-32d3-3c5f-e053-2a95a90af88b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-972-07607600972077 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-972-07) 2024-03-19NoNoHistorical
60760-972-306076009723030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-972-30) 2021-05-060000-00-00NoNoCurrent