Home NDC 63981-291 Ibuprofen
Product NDC 63981-291
11-digit product format 639810291
Labeler code 63981
Product ID 63981-291_ad3318f9-8f9a-41e6-8ad2-e42a26ce01c8
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler COSTCO WHOLESALE CORPORATION
Application ANDA075010
Marketing category ANDA
Marketing start 1988-05-24
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 2027-12-31
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 A075010-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 1999-03-01
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 A075010-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 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 3 · 53 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Listing expiration 2027-12-31 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 63981-291-03 Ibuprofen 1 in 1 PACKAGE TABLET, FILM COATED 1 20 63981-291-03 Ibuprofen 10 in 1 BOTTLE TABLET, FILM COATED 10 20 63981-291-14 Ibuprofen 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] 4 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] 4 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] 4 LACTOSE INACTIVE INGREDIENT J2B2A4N98G IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] 4 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63981-291 IBUPROFEN TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION] 18 Current NDC, Legacy NDC, 3 package rows 20250418_a50abf26-d6e5-10e4-ea90-a40b96a887e5.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63981-291-03 63981029103 1 BOTTLE in 1 PACKAGE (63981-291-03) > 10 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1988-05-24 0000-00-00 Yes No Current 63981-291-14 63981029114 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63981-291-14) 1988-05-24 0000-00-00 No No Current