Lansoprazole

Product NDC
80425-0174
11-digit product format
804250174
Labeler code
80425
Product ID
80425-0174_2a99b1dd-bed3-79f9-e063-6394a90a35f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA205868
Marketing category
ANDA
Marketing start
2018-06-04
Substance
LANSOPRAZOLE
Active strength
30 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
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui311277

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
80425-0174-1LansoprazoleDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0174-1EA - Each80425-0174bd3ee179-b80f-471f-9d2e-ac583382ce1a12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0174LANSOPRAZOLE DR (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 1 package rows20250101_ce1a4f32-da65-29d3-e053-2995a90a42ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNce1a4f32-da65-29d3-e053-2995a90a42ee6
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDce1a4f32-da65-29d3-e053-2995a90a42ee6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0174-18042501740130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0174-1) 2018-06-040000-00-00NoNoCurrent