Lansoprazole

Product NDC
80425-0148
11-digit product format
804250148
Labeler code
80425
Product ID
80425-0148_2a99c981-daed-71e5-e063-6294a90a5c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA091269
Marketing category
ANDA
Marketing start
2010-10-15
Substance
LANSOPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Inhibition Gastric Acid Secretion [PE], 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
Lansoprazole
Brand name suffix
DR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui596843

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0148-1LansoprazoleDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
80425-0148-2LansoprazoleDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0148-1EA - Each80425-0148e2277101-3e43-41e4-8411-41d918ce09bc12023-06-06
80425-0148-2EA - Each80425-0148718c791b-ef6b-43b3-9316-78a147de838012023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0148LANSOPRAZOLE DR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_c77da981-9260-fabd-e053-2a95a90aa71c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNc77da981-9260-fabd-e053-2a95a90aa71c6
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDc77da981-9260-fabd-e053-2a95a90aa71c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0148-18042501480130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0148-1) 2010-10-150000-00-00NoNoCurrent
80425-0148-28042501480260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0148-2) 2010-10-150000-00-00NoNoCurrent