FDA.reportPublic FDA data

up and up lansoprazole

Product NDC
11673-280
11-digit product format
116730280
Labeler code
11673
Product ID
11673-280_cabdfda6-5225-47a0-b627-80b4cabdaba5
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Target Corporation
Application
ANDA202319
Marketing category
ANDA
Marketing start
2021-06-18
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
up and up 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
11673-280-01up and up lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE144
11673-280-03up and up lansoprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-280UP AND UP LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TARGET CORPORATION]4Current NDC, Legacy NDC, 2 package rows20250426_16ceaead-8dc0-49de-9438-caa146e13fba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN16ceaead-8dc0-49de-9438-caa146e13fba4
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD16ceaead-8dc0-49de-9438-caa146e13fba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-280-01116730280011 BOTTLE in 1 CARTON (11673-280-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2021-06-180000-00-00NoNoCurrent
11673-280-03116730280033 BOTTLE in 1 CARTON (11673-280-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (11673-280-01) 3 bottle2021-06-180000-00-00NoNoCurrent