Home Applications 077349 Application 077349
Type ANDA
Sponsor PERRIGO R AND D Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 200MG No 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 A077349-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21
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 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077349-001 IBUPROFEN 200MG TABLET / ORAL RS 2005-06-21 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 · 21 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 120 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0074 Good Sense ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-0074 Good Sense ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-0517 Good Sense ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-0517 Good Sense ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-0517 Good Sense ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-7517 basic care ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0113-7517 basic care ibuprofen Ibuprofen L. Perrigo Company ANDA Current 0363-1517 ibuprofen 200 Ibuprofen Walgreen Company ANDA Current 11673-183 up and up ibuprofen Ibuprofen Target Corporation ANDA Current 11673-183 up and up ibuprofen Ibuprofen Target Corporation ANDA Current 11673-517 up and up ibuprofen Ibuprofen Target Corporation ANDA Current 11673-517 up and up ibuprofen Ibuprofen Target Corporation ANDA Current 21130-877 signature care ibuprofen Ibuprofen Safeway ANDA Current 21130-877 signature care ibuprofen Ibuprofen Safeway ANDA Current 24385-058 Good Neighbor Pharmacy ibuprofen Ibuprofen Amerisource Bergen ANDA Current 24385-058 Good Neighbor Pharmacy ibuprofen Ibuprofen Amerisource Bergen ANDA Current 24385-059 Good Neighbor Pharmacy ibuprofen Ibuprofen Amerisource Bergen ANDA Current 24385-059 Good Neighbor Pharmacy ibuprofen Ibuprofen Amerisource Bergen ANDA Current 24385-059 Good Neighbor Pharmacy ibuprofen Ibuprofen Amerisource Bergen ANDA Current 24385-059 Good Neighbor Pharmacy ibuprofen Ibuprofen Amerisource Bergen ANDA Current 30142-074 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-074 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-183 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-183 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-183 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-517 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-517 ibuprofen Ibuprofen Kroger Company ANDA Current 30142-517 ibuprofen Ibuprofen Kroger Company ANDA Current 36800-074 Topcare Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-074 Topcare Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-074 Topcare Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-183 Topcare Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-183 Topcare Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-183 Topcare Ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-517 Topcare ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-517 Topcare ibuprofen Ibuprofen Topco Associates LLC ANDA Current 36800-517 Topcare ibuprofen Ibuprofen Topco Associates LLC ANDA Current 37012-074 Ibuprofen Ibuprofen Shopko Stores Operating Co., LLC ANDA Current 37012-074 Ibuprofen Ibuprofen Shopko Stores Operating Co., LLC ANDA Current 37808-709 Ibuprofen Ibuprofen H E B ANDA Current 37808-709 Ibuprofen Ibuprofen H E B ANDA Current 41190-517 ShopRite Ibuprofen IB Ibuprofen Wakefern Food Corporation ANDA Current 41250-074 ibuprofen Ibuprofen Meijer Distribution Inc ANDA Current 41520-495 CareOne Ibuprofen Ibuprofen American Sales Company ANDA Current 41520-695 CareOne Ibuprofen Ibuprofen American Sales Company ANDA Current 49035-517 Equate Ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49035-517 Equate Ibuprofen Ibuprofen Wal-Mart Stores Inc ANDA Current 49348-727 sunmark ibuprofen ib Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-727 sunmark ibuprofen ib Ibuprofen McKesson ANDA Current 49348-727 sunmark ibuprofen ib Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-927 Sunmark ibuprofen ib Ibuprofen Strategic Sourcing Services LLC ANDA Current 49348-927 Sunmark ibuprofen ib Ibuprofen McKesson ANDA Current 49348-927 Sunmark ibuprofen ib Ibuprofen Strategic Sourcing Services LLC ANDA Current 49738-517 smart sense ibuprofen Ibuprofen Kmart Corporation ANDA Current 49738-517 smart sense ibuprofen Ibuprofen Kmart Corporation ANDA Current 50269-000 MOTRIN IB IBUPROFEN JC World Bell Wholesale Co., Inc. ANDA Current 50269-000 MOTRIN IB IBUPROFEN JC World Bell Wholesale Co., Inc. ANDA Current 50269-000 MOTRIN IB IBUPROFEN JC World Bell Wholesale Co., Inc. ANDA Current 50269-000 MOTRIN IB IBUPROFEN JC World Bell Wholesale Co., Inc. ANDA Current 50580-230 Motrin IB Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-230 Motrin IB Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-230 Motrin IB Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-230 Motrin IB Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-230 Motrin IB Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-230 Motrin IB Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-230 Motrin IB Ibuprofen Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50594-005 sound body ibuprofen Ibuprofen Big Lots Stores, Inc. ANDA Current 50594-005 sound body ibuprofen Ibuprofen Big Lots Stores, Inc. ANDA Current 52904-947 Motrin IB ibuprofen Select Corporation ANDA Current 55316-517 Healthy Accents ibuprofen Ibuprofen DZA Brands LLC ANDA Current 55319-517 family wellness ibuprofen ib Ibuprofen Family Dollar Services Inc ANDA Current 55910-074 DG Health Ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-074 DG Health Ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-074 DG Health Ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-074 DG Health Ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-074 DG Health Ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-517 rexall ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-517 rexall ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-517 rexall ibuprofen Ibuprofen Dolgencorp, LLC ANDA Current 55910-758 dg health ibuprofen Ibuprofen Dolgencorp Inc ANDA Current