FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
67877-443
11-digit product format
678770443
Labeler code
67877
Product ID
67877-443_f3b11232-76f6-4cfd-84ac-73df3fa0d3a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
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
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
67877-443-30Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3018
67877-443-33Rabeprazole Sodium10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1018
67877-443-38Rabeprazole Sodium100 in 1 CARTONTABLET, DELAYED RELEASE10018
67877-443-38Rabeprazole Sodium1 in 1 POUCHTABLET, DELAYED RELEASE118
67877-443-90Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-443-30EA - Each67877-4437b45b1a3-3c42-42eb-9cb3-66061de665bd12018-11-06
67877-443-90EA - Each67877-443b88d448e-94bc-47bb-9bfc-15de4e5ef7b612018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-443RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ASCEND LABORATORIES, LLC]18Current NDC, Legacy NDC, 5 package rows20231205_45092108-7c4a-48f9-8222-ca8612e82189.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN8d8c1a72-b4c4-4699-b9c3-3a39a9df44f2100
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD8d8c1a72-b4c4-4699-b9c3-3a39a9df44f2100
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN45092108-7c4a-48f9-8222-ca8612e8218918
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD45092108-7c4a-48f9-8222-ca8612e8218918
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN63e0b7ca-6b2d-42a9-b9d4-4523b8a2042513
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD63e0b7ca-6b2d-42a9-b9d4-4523b8a2042513
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNb354053c-cb83-79c6-e053-2a95a90afdbe10
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb354053c-cb83-79c6-e053-2a95a90afdbe10
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNbdad0b58-495e-2352-e053-2a95a90a31989
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN9ea2552c-873c-4ab2-84b0-dd54e84e4eee9
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDbdad0b58-495e-2352-e053-2a95a90a31989
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD9ea2552c-873c-4ab2-84b0-dd54e84e4eee9
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNb1b7def0-834f-37f5-e053-2a95a90ade1f8
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb1b7def0-834f-37f5-e053-2a95a90ade1f8
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNac9266ed-a9b2-4e77-8607-393b5dcdd2b67
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN9237eaa4-8eec-fb2a-e053-2995a90ab6c07
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDac9266ed-a9b2-4e77-8607-393b5dcdd2b67
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD9237eaa4-8eec-fb2a-e053-2995a90ab6c07
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN68b7a793-f22b-4609-a640-94fdec703d935
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN4ded337a-31b8-47c3-b5ab-33a785afb7d85
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD68b7a793-f22b-4609-a640-94fdec703d935
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD4ded337a-31b8-47c3-b5ab-33a785afb7d85
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN3b6a25c2-fb61-4c86-9988-c6ffac7939c42
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD3b6a25c2-fb61-4c86-9988-c6ffac7939c42
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNb28a4c72-9dfa-7867-e053-2995a90a9aec1
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN3a674849-b2f6-5f43-e063-6294a90a9e201
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD3a674849-b2f6-5f43-e063-6294a90a9e201
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb28a4c72-9dfa-7867-e053-2995a90a9aec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-443-306787704433030 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-443-30) 2018-04-270000-00-00NoNoCurrent
67877-443-336787704433310 in 1 BLISTER PACKHistorical
67877-443-3867877044338100 POUCH in 1 CARTON (67877-443-38) / 1 BLISTER PACK in 1 POUCH / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67877-443-33) 100 pouch2018-04-270000-00-00NoNoCurrent
67877-443-906787704439090 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-443-90) 2018-04-270000-00-00NoNoCurrent