Home NDC 0363-1610-31 IBUPROFEN
Product NDC 0363-1610
Requested package NDC 0363-1610-31
11-digit product format 003631610
Labeler code 0363
Product ID 0363-1610_13af6333-7380-e54c-e063-6294a90aaa35
Type HUMAN OTC DRUG
Nonproprietary name IBUPROFEN
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler WALGREENS
Application ANDA079205
Marketing category ANDA
Marketing start 2016-01-27
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 A079205-001 IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26
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 A079205-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2009-06-26 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 · 25 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Harris Teeter 87ffbf01-54de-45a8-b2a3-367d21927882 2026-07-29 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen Minis IBUPROFEN Grocery Outlet, Inc. 44665e3d-37a7-a1a7-e063-6294a90ab376 2026-03-04 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN WALGREENS 40a1e525-fb1e-08f4-e063-6294a90adfa7 2026-01-14 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 IBUPROFEN IBUPROFEN TIME CAP LABORATORIES, INC e0a8315a-80a5-4be3-aad1-3d01f00df494 2025-12-29 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN AMERIFOODS TRADING COMPANY 3802ebc9-83ca-602a-e063-6294a90a11c8 2025-11-20 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN BJWC (Berkley & Jensen / BJ's) 2f322afb-bfc8-9dab-e063-6394a90a08b5 2025-08-19 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN FSA STORE INC. ec6b1b86-46fc-7e82-e053-2a95a90ac147 2025-08-12 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN MARC GLASSMAN, INC. 7f366669-9d31-46c7-932d-02fa64b11f30 2025-07-15 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI 37eaa3b1-98e9-4fcf-ae74-153bfc35551f 2025-07-01 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 IBUPROFEN IBUPROFEN SPIRIT PHARMACEUTICALS,LLC 2810122e-3c89-49a2-8dac-db3714cb7b45 2024-12-30 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN Winco Foods, LLC 61cd9140-eded-4bcf-894b-a163fa5f3e10 2024-12-06 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 PROPRINAL IBUPROFEN CAPSULES 200 MG HART Health ec27b625-a3fa-4c5f-8134-c9373c09b3e3 2024-12-04 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN BETTER LIVING BRANDS, LLC eb619068-be71-7569-e053-2a95a90a4a6e 2024-10-26 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 IBUPROFEN IBUPROFEN Kroger Company bc178013-ab2e-04f5-e053-2995a90a1ed4 2024-04-13 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN KROGER COMPANY 0fbe42d0-b5f0-0780-e063-6394a90a4ecb 2024-04-13 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 IBUPROFEN IBUPROFEN WALGREENS 3ce5b71b-f841-444f-bf66-023e4bd9aa16 2024-03-15 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 ndc (package): 0363-1610-31 ndc (product): 0363-1610 ndc11 (package): 00363161031 PROPRINAL IBUPROFEN CAPSULES 200 MG A-S Medication Solutions 4723dd14-5d20-4a9a-b127-4237d5db5956 2024-01-29 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 IBUPROFEN IBUPROFEN TARGET CORPORATION 8e8646fe-fd62-1662-e053-2a95a90a3008 2024-01-03 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen Mini IBUPROFEN MINI 200 MG TARGET CORPORATION c80426d9-e121-c24d-e053-2a95a90acf2f 2024-01-03 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205 Ibuprofen IBUPROFEN TIME CAP LABORATORIES, INC. 059cb22f-f6db-5d03-e063-6294a90a9ec1 2023-10-27 Warnings Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Additional Listing Data#
Finished product Yes
Brand name base IBUPROFEN
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 310964 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-1610-23 IBUPROFEN 20 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 20 4 0363-1610-31 IBUPROFEN 300 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 300 4 0363-1610-44 IBUPROFEN 40 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 40 4 0363-1610-66 IBUPROFEN 160 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 160 4 0363-1610-80 IBUPROFEN 80 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 80 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-1610 IBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS] 4 Current NDC, Legacy NDC, 5 package rows 20240316_3ce5b71b-f841-444f-bf66-023e4bd9aa16.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 0363-1610-31 00363161031 300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-1610-31) 2016-01-27 0000-00-00 No No Current