Dexlansoprazole

Product NDC
51407-746
11-digit product format
514070746
Labeler code
51407
Product ID
51407-746_4f9c3671-b27a-e02e-e063-6294a90a176b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexlansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA202666
Marketing category
ANDA
Marketing start
2022-09-16
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, 833213

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
51407-746-30Dexlansoprazoledelayed release30 in 1 BOTTLECAPSULE, DELAYED RELEASE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-746-30EA - Each51407-746a180e4b4-cc70-4458-acb1-569a964b239c12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-746DEXLANSOPRAZOLE DELAYED RELEASE (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]5Current NDC, 1 package rows20250303_f799b9b6-ba79-f335-e053-6294a90aaa68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833204dexlansoprazole 30 MG Delayed Release Oral CapsulePSNf799b9b6-ba79-f335-e053-6294a90aaa688
833213dexlansoprazole 60 MG Delayed Release Oral CapsulePSNf799b9b6-ba79-f335-e053-6294a90aaa688
833204dexlansoprazole 30 MG Delayed Release Oral CapsuleSCDf799b9b6-ba79-f335-e053-6294a90aaa688
833213dexlansoprazole 60 MG Delayed Release Oral CapsuleSCDf799b9b6-ba79-f335-e053-6294a90aaa688

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-746-305140707463030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-746-30) 2023-01-11NoNoHistorical