Home NDC 63981-517 kirkland signature ibuprofen ib
Product NDC 63981-517
11-digit product format 639810517
Labeler code 63981
Product ID 63981-517_075b2997-0456-40bd-890a-63fd44c609a1
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Costco Wholesale Company
Application ANDA077349
Marketing category ANDA
Marketing start 2007-06-22
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077349-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 2 · 21 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base kirkland signature ibuprofen ib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310965 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63981-517-59 kirkland signature ibuprofen ib 750 in 1 BOTTLE TABLET, FILM COATED 750 8 63981-517-90 kirkland signature ibuprofen ib 500 in 1 BOTTLE TABLET, FILM COATED 500 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3 IBUPROFEN ACTIVE MOIETY WK2XYI10QM KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63981-517 KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY] 8 Current NDC, Legacy NDC, 2 package rows 20241022_2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63981-517-59 63981051759 750 in 1 BOTTLE Historical 63981-517-90 63981051790 500 TABLET, FILM COATED in 1 BOTTLE (63981-517-90) 2014-12-11 0000-00-00 No No Current