FDA.reportPublic FDA data

Good Sense Lansoprazole

Product NDC
0113-1114
11-digit product format
001131114
Labeler code
0113
Product ID
0113-1114_ffb6fcd4-466b-4d67-868a-4c7bd3827955
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA202319
Marketing category
ANDA
Marketing start
2021-11-22
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
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
0113-1114-01Good Sense Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
0113-1114-01Good Sense Lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE13
0113-1114-02Good Sense Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
0113-1114-02Good Sense Lansoprazole2 in 1 CARTONCAPSULE, DELAYED RELEASE23
0113-1114-03Good Sense Lansoprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE33
0113-1114-03Good Sense Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1114GOOD SENSE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 6 package rows20240625_91d69826-df5c-47a2-b852-3083629d1893.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN91d69826-df5c-47a2-b852-3083629d18933
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD91d69826-df5c-47a2-b852-3083629d18933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-1114-01001131114011 BOTTLE in 1 CARTON (0113-1114-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2021-11-220000-00-00NoNoCurrent
0113-1114-02001131114022 BOTTLE in 1 CARTON (0113-1114-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2021-11-220000-00-00NoNoCurrent
0113-1114-03001131114033 BOTTLE in 1 CARTON (0113-1114-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2021-11-220000-00-00NoNoCurrent