FDA.reportPublic FDA data

lansoprazole

Product NDC
0363-1212
11-digit product format
003631212
Labeler code
0363
Product ID
0363-1212_d32b65ad-abfe-4e02-a26f-88c719d0941b
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA202319
Marketing category
ANDA
Marketing start
2021-06-07
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
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
0363-1212-01lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE17
0363-1212-01lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE147
0363-1212-02lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE147
0363-1212-02lansoprazole2 in 1 CARTONCAPSULE, DELAYED RELEASE27
0363-1212-03lansoprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE37
0363-1212-03lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE147

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1212LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]7Current NDC, Legacy NDC, 6 package rows20250515_afcd7c51-9333-4d6f-ad18-ed95baecc7ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNafcd7c51-9333-4d6f-ad18-ed95baecc7ce7
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDafcd7c51-9333-4d6f-ad18-ed95baecc7ce7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1212-01003631212011 BOTTLE in 1 CARTON (0363-1212-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2021-06-070000-00-00NoNoCurrent
0363-1212-02003631212022 BOTTLE in 1 CARTON (0363-1212-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2021-06-070000-00-00NoNoCurrent
0363-1212-03003631212033 BOTTLE in 1 CARTON (0363-1212-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2021-06-070000-00-00NoNoCurrent