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 1 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Ince7175dc9-db39-4452-a419-85af179de4222026-07-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENBryant Ranch Prepackd6460cc3-c207-44e0-bf78-ad6fef055ed52026-07-09WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 71335-2047
ibuprofenIBUPROFENUnit Dose Solutions, Inc.551535ce-eab0-bb13-e063-6294a90a20702026-06-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Berkley and Jensen IbuprofenIBUPROFENBJWCcda57e42-6106-46ee-82d1-479a692ee5bb2026-05-21WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 68391-604
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen085dcc1a-e4b0-4d08-9476-72275382d1a12026-05-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.f1a03b1f-2d87-43cc-b256-bd296ccd09f22026-05-13WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENKroger Company6307485a-8be6-40ee-899b-00eb3ee8ce612026-05-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
CounterAct IBIBUPROFENMelaleuca, Inc7fafc13e-3fee-ace3-e053-2a91aa0ac2ea2026-03-17Boxed warning, WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderd673266c-3d2b-479f-9b53-cdd1b86513932026-02-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 70000-0175
ibuprofenIBUPROFENHyVee Inc4c24c884-55f7-40b4-8d6f-db6144d5ebcb2026-02-05WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Inc5233c409-3743-4312-9f75-14ded6755b5c2026-02-02WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equate ibuprofenIBUPROFENWal-Mart Stores Incb29034a6-657b-426f-a41a-5e64c4bc759d2026-01-20WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENCVS Pharmacyace493e6-91bc-41aa-8e5c-5bc14981de912026-01-06WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENNorthwind Health Company, LLCda6c2802-5d15-dbcb-e053-2a95a90a25612026-01-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENNuCare Pharmaceuticals, Inc.463ea713-6b27-b00b-e063-6394a90a86462025-12-18WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.96bff700-bca3-4b94-b8a2-379102721db82025-12-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 72789-191
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.c447fc6b-e9ef-447a-9609-5f893e18dfa72025-11-17WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
GOODNOW PAIN RELIEFIBUPROFENGobrands, Inc0759085d-6ac3-446b-ac2c-8dc30e32e1d12025-11-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
IbuprofenIBUPROFENRite Aid Corporation1dba3cb7-2e3d-4378-93cf-92db8f24f41f2025-10-09WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096

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 3 of 3 · 221 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64024-604welby health ibuprofenIbuprofenAldi, IncANDACurrent
64024-604welby health ibuprofenIbuprofenAldi, IncANDACurrent
67046-302IbuprofenIbuprofenContract Pharmacy Services-PAANDACurrent
67046-303IbuprofenIbuprofenContract Pharmacy Services-PAANDACurrent
68071-2527IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2527IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2669IbuprofenIbuprofenNuCare Pharmaceuticals,Inc.ANDACurrent
68196-005members mark ibuprofenIbuprofenSam's West IncANDACurrent
68196-005members mark ibuprofenIbuprofenSam's West IncANDACurrent
68196-005members mark ibuprofenIbuprofenSam's West IncANDACurrent
68391-604Berkley and Jensen IbuprofenIbuprofenBJWCANDACurrent
68391-604Berkley and Jensen IbuprofenIbuprofenBJWCANDACurrent
68788-7983ibuprofenIbuprofenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7983ibuprofenIbuprofenPreferred Pharmaceuticals Inc.ANDACurrent
68788-8148ibuprofenIbuprofenPreferred Pharmaceuticals Inc.ANDACurrent
69822-693Ibuprofen 200mgIbuprofen 200mgSouthern Sales & Services, Inc.ANDACurrent
70000-0175Leader IbuprofenIbuprofenCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0175Leader IbuprofenIbuprofenCardinal HealthANDACurrent
70000-0175Leader IbuprofenIbuprofenCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0175Leader IbuprofenIbuprofenCardinal HealthANDACurrent
70000-0175Leader IbuprofenIbuprofenCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0175Leader IbuprofenIbuprofenCardinal HealthANDACurrent
70000-0176Leader IbuprofenIbuprofenCardinal HealthANDACurrent
70000-0176Leader IbuprofenIbuprofenCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0176Leader IbuprofenIbuprofenCardinal HealthANDACurrent
70518-2284ibuprofenIbuprofenREMEDYREPACK INC.ANDACurrent
70518-2284ibuprofenIbuprofenREMEDYREPACK INC.ANDACurrent
70518-2284ibuprofenIbuprofenREMEDYREPACK INC.ANDACurrent
70518-2284ibuprofenIbuprofenREMEDYREPACK INC.ANDACurrent
70925-604Humana Pharmacy IbuprofenIbuprofenHumana Pharmacy, Inc.ANDACurrent
70925-604Humana Pharmacy IbuprofenIbuprofenHumana Pharmacy, Inc.ANDACurrent
70934-459ibuprofenIbuprofenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-498ibuprofenIbuprofenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71141-007IbuprofenIbuprofenLidl US LLCANDACurrent
71141-007IbuprofenIbuprofenLidl US LLCANDACurrent
71205-357ibuprofenIbuprofenProficient Rx LPANDACurrent
71205-357ibuprofenIbuprofenProficient Rx LPANDACurrent
71205-357ibuprofenIbuprofenProficient Rx LPANDACurrent
71205-357ibuprofenIbuprofenProficient Rx LPANDACurrent
71335-0746sunmark ibuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-0746sunmark ibuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-1911ibuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-1911ibuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-2047good sense ibuprofenIbuprofenBryant Ranch PrepackANDACurrent
71335-2068ibuprofenIbuprofenBryant Ranch PrepackANDACurrent
72189-170IBUPROFENIBUPROFENDIRECTRXANDACurrent
72189-170IBUPROFENIBUPROFENDIRECTRXANDACurrent
72288-311basic care ibuprofenIbuprofenAmazon.com Services LLCANDACurrent
72288-604ibuprofenIbuprofenAmazon.com Services Inc.ANDACurrent
72288-604basic care ibuprofenIbuprofenAmazon.com Services LLCANDACurrent
72288-604ibuprofenIbuprofenAmazon.com Services LLCANDACurrent
72288-604basic care ibuprofenIbuprofenAmazon.com Services LLCANDACurrent
72789-191ibuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-191ibuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
73598-1102IBUPROFEN 100IBUPROFENJHK Inc dba American Safety & First AidANDACurrent
73598-1104IBUPROFEN 250IBUPROFENJHK Inc dba American Safety & First AidANDACurrent
76413-313IbuprofenIbuprofenCentral Texas Community Health CentersANDACurrent
80267-604betr pain reliefIbuprofenLive Betr LLCANDACurrent
80267-604betr pain reliefIbuprofenLive Betr LLCANDACurrent
80267-604betr pain reliefIbuprofenLive Betr LLCANDACurrent
81522-604caring mill ibuprofenIbuprofenFSA Store Inc.ANDACurrent