Home NDC 24979-002 Dexlansoprazole
Product NDC 24979-002
11-digit product format 249790002
Labeler code 24979
Product ID 24979-002_f0b14c23-e5a8-4449-b0e6-2e0937ba75cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexlansoprazole
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
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 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 Ingredient Strength DEXLANSOPRAZOLE 60 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii UYE4T5I70X Rxcui 833204, 833213
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 24979-002-06 Dexlansoprazole delayed release 30 in 1 BOTTLE CAPSULE, DELAYED RELEASE 30 8 24979-002-07 Dexlansoprazole delayed release 90 in 1 BOTTLE CAPSULE, DELAYED RELEASE 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24979-002 DEXLANSOPRAZOLE DELAYED RELEASE (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TWI PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20241006_8dca4887-c75a-4021-8564-b704e9e1fa3e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 24979-002-06 24979000206 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-002-06) 2022-12-01 0000-00-00 No No Current 24979-002-07 24979000207 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-002-07) 2022-12-01 0000-00-00 No No Current