FDA.reportPublic FDA data

Dexlansoprazole

Product NDC
50090-7451
11-digit product format
500907451
Labeler code
50090
Product ID
50090-7451_63e58a38-23a3-4331-a2b6-366d60a95e80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexlansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7451-0Dexlansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
50090-7451-1Dexlansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7451-0EA - Each50090-745116f9c894-44c4-4094-ad0f-5ddedfe942f312024-12-10
50090-7451-1EA - Each50090-7451ce9d1667-5cca-4cce-aaac-653f0e3ede8412024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7451DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20241114_fc3de800-bfad-4e2f-b664-d58a67550b2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833213dexlansoprazole 60 MG Delayed Release Oral CapsulePSNfc3de800-bfad-4e2f-b664-d58a67550b2f3
833213dexlansoprazole 60 MG Delayed Release Oral CapsuleSCDfc3de800-bfad-4e2f-b664-d58a67550b2f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7451-05009074510030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7451-0) 2024-11-11NoNoHistorical
50090-7451-15009074510190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7451-1) 2024-11-11NoNoHistorical