FDA.reportPublic FDA data

Dexlansoprazole

Product NDC
72162-2239
11-digit product format
721622239
Labeler code
72162
Product ID
72162-2239_e2456b53-466f-4dbc-bd4a-e21d5e487303
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexlansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202666
Marketing category
ANDA
Marketing start
2022-12-01
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
Brand name suffix
delayed release
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2239-3Dexlansoprazole delayed release30 in 1 BOTTLECAPSULE, DELAYED RELEASE30101
72162-2239-9Dexlansoprazole delayed release90 in 1 BOTTLECAPSULE, DELAYED RELEASE90101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2239-3EA - Each72162-223967cc39f9-b46c-402c-9547-ee78e109a37a12024-02-14
72162-2239-9EA - Each72162-223985173e50-1afb-486e-bc52-44ac9f38139b12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2239DEXLANSOPRAZOLE DELAYED RELEASE (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20241123_dcfe880a-b96d-4a3c-aa21-3998d0bcfe9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833213dexlansoprazole 60 MG Delayed Release Oral CapsulePSNdcfe880a-b96d-4a3c-aa21-3998d0bcfe9e101
833213dexlansoprazole 60 MG Delayed Release Oral CapsuleSCDdcfe880a-b96d-4a3c-aa21-3998d0bcfe9e101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2239-37216222390330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2239-3) 2022-12-01NoNoHistorical
72162-2239-97216222390990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2239-9) 2022-12-01NoNoHistorical