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 3 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate IbuprofenIBUPROFENWal-Mart Stores Inc01e9b5b9-cb49-4bfa-9a90-ece8940bf7682025-02-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergena07c45b4-dc98-4b73-a1c1-84b108cf37e92025-01-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENH E Ba340ed68-debb-4c1e-97eb-82f6e9e3854f2024-12-02WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 37808-604
365 whole foods market ibuprofenIBUPROFENWhole Foods Market, INC.e914472b-c785-4c73-b37c-4d459166cf412024-11-26WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
dg health ibuprofenIBUPROFENDolgencorp, LLCfd27d4e1-8edf-4bc3-a593-6be5c3345ed02024-11-13WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENA-S Medication Solutions9ac095d2-ba19-4da1-acc9-85f7b4ae304d2024-11-04WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equate ibuprofenIBUPROFENWal-Mart Stores Inc307b0257-d636-416b-828a-f901782e9b102024-09-13WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENBryant Ranch Prepack22cb2ccc-ba4d-4069-8334-f886f0e3e8022024-07-12WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
IBUPROFEN 100IBUPROFENJHK Inc dba American Safety & First Aid218f6df9-dd04-45b6-8a45-3276691abee22024-04-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENH E Be00acbc0-352e-4ba1-8433-18a3079f67432024-04-12WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 37808-647
pain reliefIBUPROFENMeijer, Inc.1f965703-3262-4dd1-b4f8-6341786553b12024-02-07WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENA-S Medication Solutions57af05fc-30b9-4487-9a37-fb35dac4acf72024-01-29WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
dg health ibuprofenIBUPROFENDolgencorp Inc98492b9f-8f48-42dd-b026-c37dcdc5f8882024-01-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
foster and thrive ibuprofenIBUPROFENStrategic Sourcing Services LLC68d67a25-e669-47c7-8410-9f304b914ff12023-10-31WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENMeijer Distribution Ince578de96-747e-4104-8db6-e6521e6052a52023-10-09WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 41250-604
Signature Care IbuprofenIBUPROFENSafeway93edca03-fdf1-453f-8efe-5f0b8eef41e42023-09-28WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 21130-818
betr remedies ibuprofenIBUPROFENLive Betr LLC0a50820f-1dfa-45b5-824f-2c28822fc6c62023-07-26WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Good Sense IbuprofenIBUPROFENL. Perrigo Companyf9af5970-18ca-46d5-8d6c-c0fec22a66d52023-07-21WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 0113-1212
good sense ibuprofenIBUPROFENL. Perrigo Company9164f7e8-81a0-4b71-a2b3-111b2a7541bb2023-07-12WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 0113-0647
basic care ibuprofenIBUPROFENAmazon.com Services LLC3329f487-675d-440c-b7c5-d17a2b0242752023-05-31WarningsExact 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 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