FDA.reportPublic FDA data

lansoprazole

Product NDC
30142-192
11-digit product format
301420192
Labeler code
30142
Product ID
30142-192_73d22415-2668-4cd3-9afb-a4afbab4b01d
Type
HUMAN OTC DRUG
Nonproprietary name
lansoprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Kroger Company
Application
NDA208025
Marketing category
NDA
Marketing start
2019-04-05
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui351261

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-192-55lansoprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D145
30142-192-55lansoprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-192LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [KROGER COMPANY]5Current NDC, Legacy NDC, 2 package rows20250221_4c0684b5-5c18-4ed5-8185-8b5d51dce3a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSN4c0684b5-5c18-4ed5-8185-8b5d51dce3a05
351261lansoprazole 15 MG Disintegrating Oral TabletSCD4c0684b5-5c18-4ed5-8185-8b5d51dce3a05
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSY4c0684b5-5c18-4ed5-8185-8b5d51dce3a05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-192-55301420192553 CARTON in 1 CARTON (30142-192-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2019-04-050000-00-00NoNoCurrent