FDA.reportPublic FDA data

Dexlansoprazole

Product NDC
49884-148
11-digit product format
498840148
Labeler code
49884
Product ID
49884-148_d173ea78-6398-49ea-8742-5d4093250cfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexlansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Par Health USA, LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexlansoprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXLANSOPRAZOLE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUYE4T5I70X
Rxcui833204, 833213

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
72065c97-63d2-e1f2-e507-59f0b1c78119Product name520250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-148-09Dexlansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9025
49884-148-11Dexlansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-148-09EA - Each49884-148bcaaff84-efc4-4d5d-928e-ecfb907adcb812022-12-07
49884-148-11EA - Each49884-1489f1e46c7-67e2-4c05-8bd8-cd0571ccacc612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-148DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE [ENDO USA, INC.]24Current NDC, Legacy NDC, 2 package rows20240713_d7452a26-db20-42fc-868a-a3e3606ca895.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833213dexlansoprazole 60 MG Delayed Release Oral CapsulePSN3ed69e5a-aa78-4118-aa32-59a10f80c901100
833213dexlansoprazole 60 MG Delayed Release Oral CapsuleSCD3ed69e5a-aa78-4118-aa32-59a10f80c901100
833204dexlansoprazole 30 MG Delayed Release Oral CapsulePSNd7452a26-db20-42fc-868a-a3e3606ca89525
833213dexlansoprazole 60 MG Delayed Release Oral CapsulePSNd7452a26-db20-42fc-868a-a3e3606ca89525
833204dexlansoprazole 30 MG Delayed Release Oral CapsuleSCDd7452a26-db20-42fc-868a-a3e3606ca89525
833213dexlansoprazole 60 MG Delayed Release Oral CapsuleSCDd7452a26-db20-42fc-868a-a3e3606ca89525
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 startMarketing endSampleExclude flagStatus
49884-148-094988401480990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-09) 2022-11-220000-00-00NoNoCurrent
49884-148-114988401481130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-11) 2022-11-220000-00-00NoNoCurrent