Good Sense Lansoprazole

Product NDC
0113-0116
11-digit product format
001130116
Labeler code
0113
Product ID
0113-0116_a5e0ac07-7297-4c43-b706-94b5c9d94481
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
NDA208025
Marketing category
NDA
Marketing start
2017-11-28
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
Good Sense 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
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0116-55Good Sense Lansoprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D145
0113-0116-55Good Sense Lansoprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0116GOOD SENSE LANSOPRAZOLE (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [L. PERRIGO COMPANY]5Current NDC, Legacy NDC, 2 package rows20250205_d86585b7-e146-4f04-9016-412b16e06f55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSNd86585b7-e146-4f04-9016-412b16e06f555
351261lansoprazole 15 MG Disintegrating Oral TabletSCDd86585b7-e146-4f04-9016-412b16e06f555
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSYd86585b7-e146-4f04-9016-412b16e06f555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0116-55001130116553 CARTON in 1 CARTON (0113-0116-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2017-11-280000-00-00NoNoCurrent