FDA.reportPublic FDA data

Application 072096

Type
ANDA
Sponsor
PERRIGO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072096-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-12-08

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08c2088c7a36db…
2026-09-14 22:38:342026-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0884e616aacf4f…
2026-08-18 06:07:402026-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083a93d1ddd44b…

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 2 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENWalgreen Company37c9b887-190a-4daf-8199-f406913132f02025-09-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
foster and thrive ibuprofenIBUPROFENStrategic Sourcing Services LLCcfa8578c-2bcc-4aa7-bb8c-0d0e193020ed2025-08-28WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENBryant Ranch Prepack230fd746-92e0-40b6-9a90-595812bd8a182025-08-20WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader63b8d389-7feb-41d2-8970-b7d5660ccb4a2025-08-14WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Topcare IbuprofenIBUPROFENTopco Associates LLC8be375b0-c729-49de-abc5-2e7d37144b892025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen08d9477e-3033-4b74-8f81-934f39e37e552025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI9bf3546a-9f94-47b5-9b01-aed93e69d5aa2025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENCVS Pharmacye655bd64-dd82-46d8-87cc-2674beaffe202025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 59779-647
ibuprofenIBUPROFENMajor Pharmaceuticals03993008-7bd2-465f-b5a9-1cbc3c1fff022025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENPublix Super Markets Inc032decc5-9f7a-4f12-8ca4-a95a79a426c62025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 56062-647
care one ibuprofenIBUPROFENAmerican Sales Company006adf23-21ab-4a4e-aae9-c4e5877771652025-06-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 41520-604
ibuprofenIBUPROFENMeijer Distribution Inc66b19ed1-6cf9-4705-82cd-02f23c6379e72025-05-06WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
kirkland signature ibuprofenIBUPROFENCostco Wholesale Company65d8d650-9afc-44f7-9409-a3aa3014d4ab2025-04-24WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 63981-604
ibuprofenIBUPROFENA-S Medication Solutions504c7e5d-e721-4df8-865b-8ea17559831d2025-04-24WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 50090-5223
up and up ibuprofenIBUPROFENTarget Corporation2919fe8b-9c76-4ef6-851e-3247782cef442025-04-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIe18f4ce6-d7d3-4b53-b87a-5900ac3397f12025-04-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
TopCare IbuprofenIBUPROFENTopco Associates LLC66097f19-227c-4f9c-a7f3-ab8476e1bb6e2025-04-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENMajor Pharmaceuticals14f43c32-0895-4ef2-aa54-52b952d058fd2025-04-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Equate IbuprofenIBUPROFENWal-Mart Stores Inc01e9b5b9-cb49-4bfa-9a90-ece8940bf7682025-02-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 49035-553
Good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergena07c45b4-dc98-4b73-a1c1-84b108cf37e92025-01-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 46122-548

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 221 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
41250-801IbuprofenIbuprofenMeijer, Inc.ANDACurrent
41520-604care one ibuprofenIbuprofenAmerican Sales CompanyANDACurrent
41520-604care one ibuprofenIbuprofenAmerican Sales CompanyANDACurrent
41520-647care one ibuprofenIbuprofenAmerican Sales CompanyANDACurrent
41520-647care one ibuprofenIbuprofenAmerican Sales CompanyANDACurrent
42507-604ibuprofenIbuprofenHyVee IncANDACurrent
42507-647ibuprofenIbuprofenHyVee IncANDACurrent
42681-0026365 everday value ibuprofenIbuprofenWhole Foods Market, INC.ANDACurrent
42681-7077365 everyday value ibuprofenIbuprofenWhole Foods Market, INC.ANDACurrent
43063-890ibuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
46122-548Good neighbor pharmacy ibuprofenIbuprofenAmerisource BergenANDACurrent
46122-548Good neighbor pharmacy ibuprofenIbuprofenAmerisource BergenANDACurrent
49035-553Equate IbuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-553Equate IbuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-553Equate IbuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-604equate ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-604equate ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-604equate ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-604equate ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-604equate ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-647equate ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-647equate ibuprofenIbuprofenWal-Mart Stores IncANDACurrent
49348-196sunmark ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
49348-196sunmark ibuprofenIbuprofenMcKessonANDACurrent
49348-196sunmark ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
49348-196sunmark ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
49348-706sunmark ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
49348-706sunmark ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
49348-706sunmark ibuprofenIbuprofenMcKessonANDACurrent
49348-706sunmark ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
49738-604smart sense ibuprofenIbuprofenKmart CorporationANDACurrent
49738-604smart sense ibuprofenIbuprofenKmart CorporationANDACurrent
49738-647smart sense ibuprofenIbuprofenKmart CorporationANDACurrent
49738-647smart sense ibuprofenIbuprofenKmart CorporationANDACurrent
50090-5223ibuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-5223ibuprofenIbuprofenA-S Medication SolutionsANDACurrent
50594-020Sound Body IbuprofenIbuprofenBig Lots Stores, Inc.ANDACurrent
50594-020Sound Body IbuprofenIbuprofenBig Lots Stores, Inc.ANDACurrent
53002-5711Leader IbuprofenIbuprofenRPK Pharmaceuticals, Inc.ANDACurrent
54473-306CounterActIbuprofenMelaleuca, IncANDACurrent
55316-299Healthy Accents IbuprofenIbuprofenDZA Brands LLCANDACurrent
55316-604healthy accents ibuprofenIbuprofenDZA Brands LLCANDACurrent
55316-647Healthy Accents ibuprofenIbuprofenDZA Brands LLCANDACurrent
55319-458Family Wellness IbuprofenIbuprofenFamily Dollar Services IncANDACurrent
55319-817Family Wellness IbuprofenIbuprofenFamily Dollar Services IncANDACurrent
55319-817Family Wellness IbuprofenIbuprofenFamily Dollar Services IncANDACurrent
55910-026Rexall IbuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-026Rexall IbuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-604dg health ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-604dg health ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-604dg health ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-604dg health ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-647dg health ibuprofenIbuprofenDolgencorp, LLCANDACurrent
55910-902rexall ibuprofenIbuprofenDolgencorp IncANDACurrent
56062-604ibuprofenIbuprofenPublix Super Markets IncANDACurrent
56062-647ibuprofenIbuprofenPublix Super Markets IncANDACurrent
56062-647ibuprofenIbuprofenPublix Super Markets IncANDACurrent
59779-604ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-604ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-604ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-604ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-647ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-647ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-647ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-647ibuprofenIbuprofenCVS PharmacyANDACurrent
59779-710IbuprofenIbuprofenCVS PharmacyANDACurrent
60760-529ibuprofenIbuprofenSt. Mary's Medical Park PharmacyANDACurrent
60760-529ibuprofenIbuprofenSt. Mary's Medical Park PharmacyANDACurrent
62011-0014health mart ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0014health mart ibuprofenIbuprofenMcKessonANDACurrent
62011-0014health mart ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0014health mart ibuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0015Health Mart IbuprofenIbuprofenMcKessonANDACurrent
62011-0015Health Mart IbuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0015Health Mart IbuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
63981-604kirkland signature ibuprofenIbuprofenCostco Wholesale CompanyANDACurrent
63981-604kirkland signature ibuprofenIbuprofenCostco Wholesale CompanyANDACurrent
64024-002welby ibuprofenIbuprofenAldi, IncANDACurrent
64024-002welby ibuprofenIbuprofenAldi, IncANDACurrent
64024-002welby ibuprofenIbuprofenAldi, IncANDACurrent