FDA.reportPublic FDA data

Kirkland Signature Lansoprazole

Product NDC
63981-582
11-digit product format
639810582
Labeler code
63981
Product ID
63981-582_a0e3bf06-669d-4ed3-8eae-a155693dc439
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Costco Wholesale 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
Kirkland Signature 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
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
63981-582-01Kirkland Signature Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE144
63981-582-03Kirkland Signature Lansoprazole3 in 1 PACKAGECAPSULE, DELAYED RELEASE34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-582-03EA - Each63981-5822091c98e-f5ea-488d-b54d-d3f0e4089dbe12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-582KIRKLAND SIGNATURE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [COSTCO WHOLESALE COMPANY]4Current NDC, Legacy NDC, 2 package rows20250221_326aabe6-c4ac-4bca-949f-38015dcbaf4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN326aabe6-c4ac-4bca-949f-38015dcbaf4e4
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD326aabe6-c4ac-4bca-949f-38015dcbaf4e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-582-016398105820114 in 1 BOTTLEHistorical
63981-582-03639810582033 BOTTLE in 1 PACKAGE (63981-582-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63981-582-01) 3 bottle2021-11-220000-00-00NoNoCurrent