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 17 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC9c1ded4e-1d3b-1ab6-e053-2995a90aa80d2025-12-10WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC9c1cc205-b9e3-03fc-e053-2995a90aaffb2025-12-10WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Motrin IB, TRAVEL BASIXIBUPROFENLil' Drug Store Products, Inc.c2b99756-3e03-4d9f-9ce6-7db879afe3a12025-12-10WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENChartwell RX, LLC39f2664f-6c0a-4726-85d7-4227530d4a492025-12-10Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAAA Pharmaceutical, Inc.fbc7fb61-d295-464b-9f3b-52262ed6f31a2025-12-09WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen MigraineIBUPROFENCVS Pharmacyce54fc98-5774-4800-e053-2a95a90ad5f72025-12-08WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC45223597-0ea8-b275-e063-6394a90a84122025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC4522cb9e-4999-c455-e063-6294a90a294f2025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENStrides Pharma Science Limiteda266a3c6-932f-476f-ae93-48a785c922862025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens Ibuprofen 572IBUPROFENFamily Dollar Services, Inc.1a2182df-4339-442d-9c61-98c8b01e36fa2025-12-03WarningsName fallback
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENFamily Dollar Services, Inc.137a0290-822a-842d-e063-6294a90a5c182025-12-03WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENRedpharm Drug44f278ac-6bf9-6aef-e063-6394a90a0bb62025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENRedpharm Drug44f5743f-8c98-dc4d-e063-6294a90a6dfa2025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENRedpharm Drug44f609dd-c868-493f-e063-6294a90a71382025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUIBUPROFENProficient Rx LPa7098fa1-b5ae-485e-ada9-64154f81fb6a2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENGranules India Limited8804564c-9e1b-43c1-8b58-fd6ace645f002025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Lil Drug Store IbuprofenIBUPROFENLil Drug Store Products, Incc3be5923-9299-49b0-a455-e0c1c86985a82025-12-01WarningsName fallback
generic name: IBUPROFEN
CAREALL IbuprofenIBUPROFENNew World Imports246cf64a-162d-47a4-910a-9fb0b9be3dd12025-12-01WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENQPharma, Inc.f452d2c3-525f-4933-b146-92351d0ae44f2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutions71b5b2a2-397e-4dcb-b0c7-ef08df4337e02025-11-26Boxed 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.