Home Applications 075139 Application 075139
Type ANDA
Sponsor LNK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 200MG No No
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…
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 COSTCO WHOLESALE CORPORATION 4b8ad98e-de76-4f49-3b89-01e9dd5cde16 2026-08-06 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 63981-393 Dye Free Ibuprofen IBUPROFEN Walgreen Company d3d093f9-207a-40d4-a7be-c6b5a544a0a7 2026-08-06 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Dye Free Ibuprofen IBUPROFEN Walgreen Company 8944a0e8-2928-4494-915f-d1e0a6d4bf5c 2026-08-04 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 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 ndc (product): 70000-0291 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 ndc (product): 79481-0392 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 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
NDC Listings For This Application# NDC listings for this application page 3 of 3 · 210 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63940-393 Ibuprofen Ibuprofen Harmon Store Inc. ANDA Current 63940-393 Ibuprofen Ibuprofen Harmon Store Inc. ANDA Current 63940-393 Ibuprofen Ibuprofen Harmon Store Inc. ANDA Current 63940-393 Ibuprofen Ibuprofen Harmon Store Inc. ANDA Current 63940-393 Ibuprofen Ibuprofen Harmon Store Inc. ANDA Current 63981-393 Ibuprofen ibuprofen COSTCO WHOLESALE CORPORATION ANDA Current 63981-393 Ibuprofen ibuprofen COSTCO WHOLESALE CORPORATION ANDA Current 63981-393 Ibuprofen ibuprofen COSTCO WHOLESALE CORPORATION ANDA Current 63981-393 Ibuprofen ibuprofen COSTCO WHOLESALE CORPORATION ANDA Current 63981-393 Ibuprofen ibuprofen COSTCO WHOLESALE CORPORATION ANDA Current 63981-393 Ibuprofen ibuprofen COSTCO WHOLESALE CORPORATION ANDA Current 63981-393 Ibuprofen ibuprofen COSTCO WHOLESALE CORPORATION ANDA Current 68016-633 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-633 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-633 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-633 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-633 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-633 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-635 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-635 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-635 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-635 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-635 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 68016-635 Ibuprofen Ibuprofen Chain Drug Consortium ANDA Current 70000-0288 Ibuprofen Ibuprofen Cardinal Health 110, LLC. DBA Leader ANDA Current 70000-0288 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0288 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0288 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0288 Ibuprofen Ibuprofen Cardinal Health 110, LLC. DBA Leader ANDA Current 70000-0288 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0291 Ibuprofen Ibuprofen Cardinal Health 110, LLC. DBA Leader ANDA Current 70000-0291 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0291 Ibuprofen Ibuprofen Cardinal Health 110, LLC. DBA Leader ANDA Current 70000-0291 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0291 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0291 Ibuprofen Ibuprofen Cardinal Health 110, LLC. DBA Leader ANDA Current 70000-0291 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0292 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0292 Ibuprofen Ibuprofen Cardinal Health 110, LLC. DBA Leader ANDA Current 70000-0292 Ibuprofen Ibuprofen Cardinal Health 110, LLC. DBA Leader ANDA Current 70000-0292 Ibuprofen Ibuprofen Cardinal Health 110, LLC. DBA Leader ANDA Current 70000-0292 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0292 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70000-0292 Ibuprofen Ibuprofen Cardinal Health ANDA Current 70518-2743 Ibuprofen ibuprofen REMEDYREPACK INC. ANDA Current 70518-2743 Ibuprofen ibuprofen REMEDYREPACK INC. ANDA Current 70518-2743 Ibuprofen ibuprofen REMEDYREPACK INC. ANDA Current 70518-2743 Ibuprofen ibuprofen REMEDYREPACK INC. ANDA Current 70729-002 Dye Free Ibuprofen Ibuprofen Breeden Brothers, LLC ANDA Current 79481-0392 Ibuprofen Ibuprofen Meijer Distribution, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42949 SUPPL 2007-07-27 42948 SUPPL 2007-07-27 42947 SUPPL 2007-07-27 22429 SUPPL 2007-07-27 42946 SUPPL 2007-07-24 42945 SUPPL 2007-07-24 22428 SUPPL 2007-07-24 22427 SUPPL 2007-07-24 22426 ORIG 2007-07-24 30771 ORIG 1999-03-01