Aciphex

Product NDC
80725-243
11-digit product format
807250243
Labeler code
80725
Product ID
80725-243_cc6cb214-ac28-4c8b-9b57-7635ef896038
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Waylis Therapeutics LLC
Application
NDA020973
Marketing category
NDA
Marketing start
2022-05-15
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
Aciphex
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RABEPRAZOLE SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3L36P16U4R
Rxcui854868, 854870

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
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
80725-243-30Aciphex30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80725-243-30EA - Each80725-243d0eec9f8-544e-4368-9299-1018d4165a2a12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80725-243ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [WAYLIS THERAPEUTICS LLC]2Current NDC, 1 package rows20250129_1eb38279-0237-4967-be7a-c53a826c1138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854870AcipHex 20 MG Delayed Release Oral TabletPSN1eb38279-0237-4967-be7a-c53a826c11383
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN1eb38279-0237-4967-be7a-c53a826c11383
854870rabeprazole sodium 20 MG Delayed Release Oral Tablet [Aciphex]SBD1eb38279-0237-4967-be7a-c53a826c11383
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD1eb38279-0237-4967-be7a-c53a826c11383
854870Aciphex 20 MG Delayed Release Oral TabletSY1eb38279-0237-4967-be7a-c53a826c11383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80725-243-308072502433030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80725-243-30) 2023-12-01NoNoHistorical