Lansoprazole

Product NDC
0363-1419
11-digit product format
003631419
Labeler code
0363
Product ID
0363-1419_74993565-74a8-45d5-8dae-523dbe9cc56e
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
NDA208025
Marketing category
NDA
Marketing start
2017-05-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole
Listing expiration
2027-12-31

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1419-55Lansoprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D36
0363-1419-55Lansoprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D146
0363-1419-74Lansoprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D146
0363-1419-74Lansoprazole1 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1419LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [WALGREEN COMPANY]5Current NDC, Legacy NDC, 4 package rows20250205_a72f92cc-db49-40ef-a249-6b7c50dc8ef2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSNa72f92cc-db49-40ef-a249-6b7c50dc8ef26
351261lansoprazole 15 MG Disintegrating Oral TabletSCDa72f92cc-db49-40ef-a249-6b7c50dc8ef26
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSYa72f92cc-db49-40ef-a249-6b7c50dc8ef26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1419-55003631419553 CARTON in 1 CARTON (0363-1419-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2017-05-250000-00-00NoNoCurrent
0363-1419-74003631419741 CARTON in 1 CARTON (0363-1419-74) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK1 carton2017-05-250000-00-00NoNoCurrent