Home NDC 50844-352 Ibuprofen
Product NDC 50844-352
11-digit product format 508440352
Labeler code 50844
Product ID 50844-352_60c87666-dbaf-4d99-9985-b9a662198528
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application ANDA075139
Marketing category ANDA
Marketing start 1999-03-01
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 A075139-001 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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 cb3db0bc1861…
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 50844-352-02 Ibuprofen 12 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 12 12 50844-352-02 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 12 50844-352-12 Ibuprofen 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 12 50844-352-12 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 12 50844-352-15 Ibuprofen 1 in 1 CARTON TABLET, FILM COATED 1 12 50844-352-15 Ibuprofen 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 12 50844-352-16 Ibuprofen 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ibuprofen ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1 Ibuprofen ACTIVE MOIETY WK2XYI10QM IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1 Carnauba Wax INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1 Hypromellose INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1 Lactose INACTIVE INGREDIENT J2B2A4N98G IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1 Polydextrose INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1 Polyethylene Glycol INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1 Stearic Acid INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1 Triacetin INACTIVE INGREDIENT XHX3C3X673 IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-352 IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 11 Current NDC, Legacy NDC, 7 package rows 20250124_8ebe3e16-b7ae-d333-6671-5bc935e25900.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 2 · 26 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Better Living Brands, LLC 45520969-7a2d-4469-ba25-7db160d50ccf 2026-07-06 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. 027ded51-aa01-6619-3938-c8162a421cf3 2026-06-18 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Cardinal Health 110, LLC. DBA Leader a41a0bc2-ef7a-44cd-a42e-aefab41323cc 2026-06-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN ARMY AND AIR FORCE EXCHANGE SERVICE 01f8fe3a-8810-4b38-8860-d95e05d37709 2026-06-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Cardinal Health 107, LLC 260f5862-d65d-4c34-bf53-26ca30806a67 2026-05-19 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Meijer Distribution, Inc. 3e3a5366-535d-45fb-81af-c7d98ac20b11 2026-05-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen Dye Free IBUPROFEN CVS Pharmacy 00653b7c-7099-487e-9a01-e89781c21323 2026-04-29 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Meijer Distribution Inc 36f7227d-f3cb-44b7-a4c1-27611cd15052 2026-04-24 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Rite Aid Corporation 72e11f2d-a348-4c12-9cd8-1e6f0f6f7399 2026-04-09 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen Dye-Free IBUPROFEN Wal-Mart Stores Inc 23cb5001-6aeb-434a-b2e8-aaf8bbab9dc6 2026-04-01 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen Dye Free IBUPROFEN WALMART INC. 2b04d255-a1df-4698-9b5a-ad7a12205e1b 2026-03-25 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 pain relief ibuprofen IBUPROFEN Rite Aid Corporation 2bd1438e-27b1-81ff-f8e1-0f5b50b04581 2026-02-02 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN H E B 88c7486b-f9a7-4856-a25a-7c06e1382f1a 2026-02-02 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. 82e907e6-86a9-5c7f-93bd-a6319d74100f 2026-01-13 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. 8ebe3e16-b7ae-d333-6671-5bc935e25900 2026-01-13 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 50844-352 Ibuprofen IBUPROFEN L.N.K. International, Inc. c93da67f-f42e-4baa-976b-73c71ba6dd71 2026-01-12 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Major Pharmaceuticals 6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f6 2025-12-17 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Dye Free Ibuprofen IBUPROFEN Walgreen Company d3d093f9-207a-40d4-a7be-c6b5a544a0a7 2025-12-12 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Family Dollar Services Inc 89ed9311-2185-4660-b219-9ea67b1a71ec 2025-11-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Topco Associates, LLC bcf7d4c1-1f99-48df-8f74-9abeefa8d41d 2025-11-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139
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 50844-352-02 50844035202 1 BOTTLE, PLASTIC in 1 CARTON (50844-352-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1999-03-01 0000-00-00 No No Current 50844-352-12 50844035212 1 BOTTLE, PLASTIC in 1 CARTON (50844-352-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1999-03-01 0000-00-00 No No Current 50844-352-15 50844035215 1 BOTTLE, PLASTIC in 1 CARTON (50844-352-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1999-03-01 0000-00-00 No No Current 50844-352-16 50844035216 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-352-16) 1999-03-01 0000-00-00 No No Current