FDA.reportPublic FDA data

Application 072300

Type
ANDA
Sponsor
CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL800MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 30 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen minisIBUPROFENWR Group, Inc.e9dad35a-6789-42d6-97da-521db7b164962025-03-24WarningsName fallback
generic name: IBUPROFEN
basic care ibuprofenIBUPROFENAmazon.com Services LLC25bc5cc2-9b6a-47e4-8b3d-2bb370907b612025-03-20WarningsName fallback
generic name: IBUPROFEN
basic care ibuprofenIBUPROFENAmazon.com Services LLCcd15159a-9ed5-453a-9ad4-0c9688204c822025-03-19WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.ce5b0429-bbe1-47a4-af5e-0159d3cfd2c32025-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENCare One (Retail Business Services, LLC.)a6ce7484-7a32-4985-80bc-883c31be35252025-03-12WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
LEADER CHILDRENS IBUPROFENIBUPROFENCardinal Health 110, LLC. dba Leader913a4bd0-0784-45b4-b05e-3e7c016bbb862025-03-03WarningsName fallback
generic name: IBUPROFEN
equate ibuprofenIBUPROFENWal-Mart Stores Inc2daee8c1-d05e-406b-af65-b81bbbaa244d2025-03-03WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd02889717-204c-463b-8506-4c5cf18c77d32025-03-03WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENDiscount Drug Mart, Inc2d58d1c4-b864-6bb8-e063-6394a90a71172025-02-24WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENAurobindo Pharma Limited00872852-680a-41b3-901b-b991b12a176d2025-02-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Dye Free Childrens IbuprofenIBUPROFENPrecision Dose Inc.eccee4c6-aa94-468a-aebd-265d7a9efb6d2025-02-12WarningsName fallback
generic name: IBUPROFEN
Equate IbuprofenIBUPROFENWal-Mart Stores Inc01e9b5b9-cb49-4bfa-9a90-ece8940bf7682025-02-11WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENBrisk Pharmaceuticals2dcbe4bb-fb24-e827-e063-6394a90acf9f2025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen infants DropsIBUPROFENHarris Teeter, LLC2c39a24f-4e42-d75f-e063-6394a90a60fa2025-02-04WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.fae53f7b-3948-2566-e053-6394a90aae362025-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENHarris Teeter, LLC2bb186c8-f791-5f1f-e063-6294a90a87ff2025-02-04WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.0bee69ff-cf76-175e-e063-6294a90a42f62025-02-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd2457c045-0b7c-48f4-9422-11623f13d8f12025-01-29WarningsName fallback
generic name: IBUPROFEN
AdvilIBUPROFENLil' Drug Store Products, Inc.772360bd-8631-4d24-b4db-5a7e6e1d9a132025-01-27WarningsName fallback
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltdefb728f2-fe74-4833-8f0c-710d833abf6e2025-01-27WarningsName fallback
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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