FDA.reportPublic FDA data

kirkland signature ibuprofen

Product NDC
63981-604
11-digit product format
639810604
Labeler code
63981
Product ID
63981-604_58d8bea2-6399-4004-81f0-9e64891b57de
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Costco Wholesale Company
Application
ANDA072096
Marketing category
ANDA
Marketing start
2003-06-25
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63981-604-52kirkland signature ibuprofen10 in 1 BOTTLETABLET, FILM COATED107
63981-604-90kirkland signature ibuprofen500 in 1 BOTTLETABLET, FILM COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-604-90EA - Each63981-60451c67d5a-41fa-4448-af69-11245175402d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMKIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
IBUPROFENACTIVE MOIETYWK2XYI10QMKIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48KIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675KIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTKIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AKIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HKIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJKIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APKIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-604KIRKLAND SIGNATURE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]7Current NDC, Legacy NDC, 2 package rows20250426_65d8d650-9afc-44f7-9409-a3aa3014d4ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN65d8d650-9afc-44f7-9409-a3aa3014d4ab7
310965ibuprofen 200 MG Oral TabletSCD65d8d650-9afc-44f7-9409-a3aa3014d4ab7
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY65d8d650-9afc-44f7-9409-a3aa3014d4ab7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63981-604-526398106045210 TABLET, FILM COATED in 1 BOTTLE (63981-604-52) 2018-06-140000-00-00NoNoCurrent
63981-604-9063981060490500 TABLET, FILM COATED in 1 BOTTLE (63981-604-90) 2003-06-250000-00-00NoNoCurrent