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 31 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENDirect Rxd88d0544-57a7-4a82-e053-2a95a90a19452025-01-21Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension, Dye FreeIBUPROFENBest Choice55fd05c7-b902-4c82-ab9a-8054d880dfbd2025-01-20WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENDIRECT RXc3f30813-0848-6e8a-e053-2995a90a3dea2025-01-20Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension, Bubble GumIBUPROFENBest Choiced27ca801-d4d3-4fd0-a22b-db5ada5fcb9f2025-01-20WarningsName fallback
generic name: IBUPROFEN
Childrens Ibuprofen Oral SuspensionIBUPROFENReliable 1 Laboratories LLC28dd9baa-43bd-b60a-e063-6394a90a8cf72025-01-15WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb2025-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.701ee488-c57f-a82c-e053-2991aa0af4032025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen19d3af1c-9dd5-48d9-bd5c-05cc8745e8362025-01-04WarningsName fallback
generic name: IBUPROFEN
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen7cd838e1-85da-4510-86f0-9d8bc913e8102025-01-03WarningsName fallback
generic name: IBUPROFEN
Good Neighbor Pharmacy Childrens IbuprofenIBUPROFENAmerisource Bergenb8f43352-f771-4722-b843-f3e29f77c7c02025-01-03WarningsName fallback
generic name: IBUPROFEN
Good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergena07c45b4-dc98-4b73-a1c1-84b108cf37e92025-01-03WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.9b02607a-6fab-5205-e053-2a95a90afa262025-01-02Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.fc871659-ce41-1be6-e053-6294a90aa5e42025-01-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd998f2fcf-0b40-4304-929f-7f2fa42f66d02024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENTrifecta Pharmaceuticals USA LLC09972806-e064-238d-e063-6394a90a74342024-12-31WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCaf9af7f4-6314-6217-e053-2995a90a5a0f2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCb33caad1-8d40-16f2-e053-2a95a90a1b2d2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCc859cc7a-e13a-7df4-e053-2a95a90a47d62024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCbd1ca7af-d640-23fb-e053-2a95a90a8a982024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCf18b6a0a-e42f-083d-e053-2995a90a40e42024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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