FDA.reportPublic FDA data

Dexlansoprazole

Product NDC
50090-6514
11-digit product format
500906514
Labeler code
50090
Product ID
50090-6514_f84a485f-17d9-4fae-90aa-8a4b72fe7d1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexlansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-6514-0Dexlansoprazole delayed release30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
50090-6514-1Dexlansoprazole delayed release90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6514-0EA - Each50090-6514936cbe55-26c5-4a8c-80c0-e3cd4fb2eca012023-07-06
50090-6514-1EA - Each50090-6514469a734d-99f7-45d6-b090-53d57db667f512023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6514DEXLANSOPRAZOLE DELAYED RELEASE (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230608_4f44e84f-6219-4445-a67d-df37d18b014d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833213dexlansoprazole 60 MG Delayed Release Oral CapsulePSN4f44e84f-6219-4445-a67d-df37d18b014d1
833213dexlansoprazole 60 MG Delayed Release Oral CapsuleSCD4f44e84f-6219-4445-a67d-df37d18b014d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6514-05009065140030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6514-0) 2023-06-01NoNoHistorical
50090-6514-15009065140190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6514-1) 2023-06-01NoNoHistorical