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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-10-28 04:53 UTC2022-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08f41ea6bd6efb…

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 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
careone ibuprofenIBUPROFENAmerican Sales Company2720b8aa-4361-4cd4-be26-aa6dd1692d122025-10-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
pain reliefIBUPROFENMeijer, Inc.ae39917e-1998-4298-8686-919c0d3c2b072025-09-19WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENWalgreen Company37c9b887-190a-4daf-8199-f406913132f02025-09-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 0363-0604
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
ndc (product): 36800-647
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen08d9477e-3033-4b74-8f81-934f39e37e552025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 24385-647
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI9bf3546a-9f94-47b5-9b01-aed93e69d5aa2025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 41163-647
ibuprofenIBUPROFENCVS Pharmacye655bd64-dd82-46d8-87cc-2674beaffe202025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENMajor Pharmaceuticals03993008-7bd2-465f-b5a9-1cbc3c1fff022025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 0904-7912
ibuprofenIBUPROFENPublix Super Markets Inc032decc5-9f7a-4f12-8ca4-a95a79a426c62025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
care one ibuprofenIBUPROFENAmerican Sales Company006adf23-21ab-4a4e-aae9-c4e5877771652025-06-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENMeijer Distribution Inc66b19ed1-6cf9-4705-82cd-02f23c6379e72025-05-06WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 41250-647
kirkland signature ibuprofenIBUPROFENCostco Wholesale Company65d8d650-9afc-44f7-9409-a3aa3014d4ab2025-04-24WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENA-S Medication Solutions504c7e5d-e721-4df8-865b-8ea17559831d2025-04-24WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
up and up ibuprofenIBUPROFENTarget Corporation2919fe8b-9c76-4ef6-851e-3247782cef442025-04-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 11673-604
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIe18f4ce6-d7d3-4b53-b87a-5900ac3397f12025-04-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 41163-604
TopCare IbuprofenIBUPROFENTopco Associates LLC66097f19-227c-4f9c-a7f3-ab8476e1bb6e2025-04-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 36800-604
ibuprofenIBUPROFENMajor Pharmaceuticals14f43c32-0895-4ef2-aa54-52b952d058fd2025-04-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 0904-6747

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 1 of 3 · 221 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0604good sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0604good sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0604good sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0604good sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0647good sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0647good sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-0647good sense ibuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-1212Good Sense IbuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-1212Good Sense IbuprofenIbuprofenL. Perrigo CompanyANDACurrent
0113-7604Basic Care IbuprofenIbuprofenL. Perrigo CompanyANDACurrent
0363-0604ibuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0604ibuprofenIbuprofenWalgreen CompanyANDACurrent
0363-0705ibuprofenIbuprofenWalgreen CompanyANDACurrent
0904-6747ibuprofenIbuprofenMajor PharmaceuticalsANDACurrent
0904-6747ibuprofenIbuprofenMajor PharmaceuticalsANDACurrent
0904-6747ibuprofenIbuprofenMajor PharmaceuticalsANDACurrent
0904-7912ibuprofenIbuprofenMajor PharmaceuticalsANDACurrent
0904-7912ibuprofenIbuprofenMajor PharmaceuticalsANDACurrent
0904-7912ibuprofenIbuprofenMajor PharmaceuticalsANDACurrent
10202-6047 select ibuprofenIbuprofen7-ElevenANDACurrent
10202-6047 select ibuprofenIbuprofen7-ElevenANDACurrent
10202-6477 Select IbuprofenIbuprofen7-ElevenANDACurrent
10202-6477 Select IbuprofenIbuprofen7-ElevenANDACurrent
11673-314up and up ibuprofenibuprofenTarget CorporationANDACurrent
11673-604up and up ibuprofenIbuprofenTarget CorporationANDACurrent
11673-604up and up ibuprofenIbuprofenTarget CorporationANDACurrent
11673-604up and up ibuprofenIbuprofenTarget CorporationANDACurrent
11673-647up and up ibuprofenIbuprofenTarget CorporationANDACurrent
11673-647up and up ibuprofenIbuprofenTarget CorporationANDACurrent
11822-6604IbuprofenIbuprofenRite Aid CorporationANDACurrent
21130-585Signature Care IbuprofenIbuprofenSafewayANDACurrent
21130-585Signature Care IbuprofenIbuprofenSafewayANDACurrent
21130-585Signature Care IbuprofenIbuprofenSafewayANDACurrent
21130-818Signature Care IbuprofenIbuprofenSafewayANDACurrent
21130-818Signature Care IbuprofenIbuprofenSafewayANDACurrent
24385-604good neighbor pharmacy ibuprofenIbuprofenAmerisource BergenANDACurrent
24385-604good neighbor pharmacy ibuprofenIbuprofenAmerisource BergenANDACurrent
24385-647good neighbor pharmacy ibuprofenIbuprofenAmerisource BergenANDACurrent
24385-647good neighbor pharmacy ibuprofenIbuprofenAmerisource BergenANDACurrent
30142-495ibuprofenIbuprofenKroger CompanyANDACurrent
30142-495ibuprofenIbuprofenKroger CompanyANDACurrent
30142-495ibuprofenIbuprofenKroger CompanyANDACurrent
30142-495ibuprofenIbuprofenKroger CompanyANDACurrent
30142-495ibuprofenIbuprofenKroger CompanyANDACurrent
30142-604ibuprofenIbuprofenKroger CompanyANDACurrent
30142-604ibuprofenIbuprofenKroger CompanyANDACurrent
30142-604ibuprofenIbuprofenKroger CompanyANDACurrent
30142-604ibuprofenIbuprofenKroger CompanyANDACurrent
30142-647IbuprofenIbuprofenKroger CompanyANDACurrent
30142-647IbuprofenIbuprofenKroger CompanyANDACurrent
30142-647IbuprofenIbuprofenKroger CompanyANDACurrent
33261-060IbuprofenIbuprofenAidarex Pharmaceuticals LLCANDACurrent
36800-604TopCare IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-604TopCare IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-604TopCare IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-604TopCare IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-647Topcare IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-647Topcare IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-647Topcare IbuprofenIbuprofenTopco Associates LLCANDACurrent
36800-647Topcare IbuprofenIbuprofenTopco Associates LLCANDACurrent
37012-272IbuprofenIbuprofenShopko Stores Operating Co., LLCANDACurrent
37012-272IbuprofenIbuprofenShopko Stores Operating Co., LLCANDACurrent
37012-604IbuprofenIbuprofenShopko Stores Operating Co., LLCANDACurrent
37012-647IbuprofenIbuprofenShopko Stores Operating Co., LLCANDACurrent
37808-604ibuprofenIbuprofenH E BANDACurrent
37808-604ibuprofenIbuprofenH E BANDACurrent
37808-647ibuprofenIbuprofenH E BANDACurrent
37808-647ibuprofenIbuprofenH E BANDACurrent
41163-604equaline ibuprofenIbuprofenSupervalu IncANDACurrent
41163-604equaline ibuprofenIbuprofenSupervalu IncANDACurrent
41163-647equaline ibuprofenIbuprofenSupervalu IncANDACurrent
41163-647equaline ibuprofenIbuprofenSupervalu IncANDACurrent
41190-604ShopRite IbuprofenIbuprofenWakefern Food CorporationANDACurrent
41190-604ShopRite IbuprofenIbuprofenWakefern Food CorporationANDACurrent
41190-647shoprite ibuprofenIbuprofenWakefern Food CorporationANDACurrent
41190-647shoprite ibuprofenIbuprofenWakefern Food CorporationANDACurrent
41250-604ibuprofenIbuprofenMeijer Distribution IncANDACurrent
41250-604ibuprofenIbuprofenMeijer Distribution IncANDACurrent
41250-647ibuprofenIbuprofenMeijer Distribution IncANDACurrent
41250-801IbuprofenIbuprofenMeijer, Inc.ANDACurrent