Dexlansoprazole

Product NDC
72162-2214
11-digit product format
721622214
Labeler code
72162
Product ID
72162-2214_f2ffd057-f79c-4337-9647-a9779b305b79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexlansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202294
Marketing category
ANDA
Marketing start
2022-11-22
Substance
DEXLANSOPRAZOLE
Active strength
60 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
Dexlansoprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXLANSOPRAZOLE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUYE4T5I70X
Rxcui833213

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
72065c97-63d2-e1f2-e507-59f0b1c78119Product name520250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2214-3Dexlansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2214-3EA - Each72162-22143f990530-ff33-46df-a17c-c151b23cb12c12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2214DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240106_3ed69e5a-aa78-4118-aa32-59a10f80c901.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833213dexlansoprazole 60 MG Delayed Release Oral CapsulePSN3ed69e5a-aa78-4118-aa32-59a10f80c901100
833213dexlansoprazole 60 MG Delayed Release Oral CapsuleSCD3ed69e5a-aa78-4118-aa32-59a10f80c901100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2214-37216222140330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2214-3) 2024-01-05NoNoCurrent