FDA.reportPublic FDA data

Application 071267

Type
ANDA
Sponsor
CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL400MGNoNo

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 13 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENMajor Pharmaceuticals42b6faf5-ef47-6a7a-e063-6394a90ac4092026-02-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENHyVee Inc4c24c884-55f7-40b4-8d6f-db6144d5ebcb2026-02-05WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
CareOne IbuprofenIBUPROFENAmerican Sales Company03cdff8a-8890-440d-82b5-54ce809f88cc2026-02-03WarningsName fallback
generic name: IBUPROFEN
Pain Relief IbuprofenIBUPROFENRite Aid Corporationc85c3d1f-7639-4cfa-bf3a-424b61757b1a2026-02-03WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENHyVee Inc5233c409-3743-4312-9f75-14ded6755b5c2026-02-02WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
pain relief ibuprofenIBUPROFENRite Aid Corporation2bd1438e-27b1-81ff-f8e1-0f5b50b045812026-02-02WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENL.N.K. International, Inc.8b5eec38-bdf3-4f27-802f-f4c732ae5c7d2026-02-02WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENH E B88c7486b-f9a7-4856-a25a-7c06e1382f1a2026-02-02WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENStrategic Sourcing Services, LLCdc469eb2-89cc-46c9-9304-f6cf119c05702026-01-29WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
CaldolorIBUPROFENCumberland Pharmaceuticals Inc.1eaa7790-f1a1-4f51-b10a-cbbaf033f6842026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENSoftgel Healthcare Private Limited2b07ace6-6766-0a06-e063-6294a90ad1bd2026-01-27WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENMajor Pharmaceuticals847758ed-66fc-4db9-8fdb-78f3c3291a032026-01-26WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENCVS Pharmacy8d9f11a5-ca98-4280-9c6a-093d32e60ace2026-01-22WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
equate ibuprofenIBUPROFENWal-Mart Stores Incb29034a6-657b-426f-a41a-5e64c4bc759d2026-01-20WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.70e191ef-8fad-49eb-9850-fceea119e92f2026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.b84ea215-e61d-4c00-8a34-d47c4080779b2026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENWALGREENS40a1e525-fb1e-08f4-e063-6294a90adfa72026-01-14WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENL.N.K. International, Inc.82e907e6-86a9-5c7f-93bd-a6319d74100f2026-01-13WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENHYVEE INC45aead8a-37ee-9a66-e063-6394a90a5d172026-01-13WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENHYVEE INC459fc063-0664-09b7-e063-6394a90a89e02026-01-13WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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