Dexlansoprazole

Product NDC
71335-3071
11-digit product format
713353071
Labeler code
71335
Product ID
71335-3071_fc47d0ec-8924-4944-8bb5-96368d9c2b06
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
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

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
71335-3071-1Dexlansoprazole delayed release30 in 1 BOTTLECAPSULE, DELAYED RELEASE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
71335-3071-17133530710130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3071-1) 2026-02-09NoNoHistorical