Home NDC 63981-598 Ibuprofen
Product NDC 63981-598
11-digit product format 639810598
Labeler code 63981
Product ID 63981-598_5be7cede-b6cd-4b27-9f53-33e149b6bfa2
Type HUMAN OTC DRUG
Nonproprietary name IBUPROFEN
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Costco Wholesale
Application ANDA078682
Marketing category ANDA
Marketing start 2018-02-06
Marketing end 2026-12-28
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
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 A078682-001 IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24
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 A078682-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-03-24 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 · 60 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen 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 310964 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 63981-598-36 Ibuprofen 2 in 1 BOX CAPSULE, LIQUID FILLED 2 7 63981-598-36 Ibuprofen 180 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 180 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63981-598 IBUPROFEN CAPSULE, LIQUID FILLED [COSTCO WHOLESALE] 5 Current NDC, Legacy NDC, 2 package rows 20230412_b4fa56d3-f4be-45b2-a3ac-40fe8d8bea07.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 63981-598-36 63981059836 2 BOTTLE, PLASTIC in 1 BOX (63981-598-36) / 180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2018-02-06 2026-12-28 No No Current