FDA.reportPublic FDA data

Dexlansoprazole

Product NDC
24979-001
11-digit product format
249790001
Labeler code
24979
Product ID
24979-001_f0b14c23-e5a8-4449-b0e6-2e0937ba75cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexlansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA202666
Marketing category
ANDA
Marketing start
2022-12-01
Substance
DEXLANSOPRAZOLE
Active strength
30 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
Dexlansoprazole
Brand name suffix
delayed release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXLANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUYE4T5I70X
Rxcui833204, 833213

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
72065c97-63d2-e1f2-e507-59f0b1c78119Product name520250114

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24979-001-06Dexlansoprazole delayed release30 in 1 BOTTLECAPSULE, DELAYED RELEASE308
24979-001-07Dexlansoprazole delayed release90 in 1 BOTTLECAPSULE, DELAYED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-001-06EA - Each24979-001a13ecde6-c0f6-4a14-a71d-26847a92b42512023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-001DEXLANSOPRAZOLE DELAYED RELEASE (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TWI PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20241006_8dca4887-c75a-4021-8564-b704e9e1fa3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833204dexlansoprazole 30 MG Delayed Release Oral CapsulePSN8dca4887-c75a-4021-8564-b704e9e1fa3e9
833213dexlansoprazole 60 MG Delayed Release Oral CapsulePSN8dca4887-c75a-4021-8564-b704e9e1fa3e9
833204dexlansoprazole 30 MG Delayed Release Oral CapsuleSCD8dca4887-c75a-4021-8564-b704e9e1fa3e9
833213dexlansoprazole 60 MG Delayed Release Oral CapsuleSCD8dca4887-c75a-4021-8564-b704e9e1fa3e9
833204dexlansoprazole 30 MG Delayed Release Oral CapsulePSNf799b9b6-ba79-f335-e053-6294a90aaa688
833213dexlansoprazole 60 MG Delayed Release Oral CapsulePSNf799b9b6-ba79-f335-e053-6294a90aaa688
833204dexlansoprazole 30 MG Delayed Release Oral CapsuleSCDf799b9b6-ba79-f335-e053-6294a90aaa688
833213dexlansoprazole 60 MG Delayed Release Oral CapsuleSCDf799b9b6-ba79-f335-e053-6294a90aaa688
833204dexlansoprazole 30 MG Delayed Release Oral CapsulePSN31d3d485-5f87-4405-b940-490fa4ccf9cc1
833204dexlansoprazole 30 MG Delayed Release Oral CapsuleSCD31d3d485-5f87-4405-b940-490fa4ccf9cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24979-001-062497900010630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-001-06) 2022-12-010000-00-00NoNoCurrent
24979-001-072497900010790 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-001-07) 2022-12-010000-00-00NoNoCurrent