Dexlansoprazole

Product NDC
72162-2244
11-digit product format
721622244
Labeler code
72162
Product ID
72162-2244_b5a71d4c-fa7f-4689-acef-1462333db6db
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
2023-06-10
Substance
DEXLANSOPRAZOLE
Active strength
30 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
DEXLANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUYE4T5I70X
Rxcui833204

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
72162-2244-3Dexlansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2244-3EA - Each72162-22446385b8fe-ef87-418c-aab2-be9d40ab2dcf12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2244DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240130_caad4ada-2cf9-4e12-99df-6ca4388cf0f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833204dexlansoprazole 30 MG Delayed Release Oral CapsulePSNcaad4ada-2cf9-4e12-99df-6ca4388cf0f6100
833204dexlansoprazole 30 MG Delayed Release Oral CapsuleSCDcaad4ada-2cf9-4e12-99df-6ca4388cf0f6100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2244-37216222440330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2244-3) 2024-01-29NoNoHistorical