Home Applications 072300 Application 072300
Type ANDA
Sponsor CONTRACT PHARMACAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 800MG No No
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 8 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Redpharm Drug 5302291e-4816-8495-e063-6394a90a9cc0 2026-05-30 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Wal-Mart Stores Inc cb897d65-7e98-4d02-be64-0704416a0f29 2026-05-28 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Family Dollar (FAMILY WELLNESS) 5beb7c11-4ed4-4cd4-9c30-3b0c4016316f 2026-05-27 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN Rite Aid Corporation 1da544eb-ed4e-4124-bea3-f827f1322270 2026-05-27 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Family Dollar (FAMILY WELLNESS) da16b1a9-0db2-4f2f-bc85-05ea5ab26e1c 2026-05-27 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Motrin IB IBUPROFEN Select Consumer Group LLC 52c650cf-3085-7b2c-e063-6394a90a797f 2026-05-27 Warnings Name fallback generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN NuCare Pharmaceuticals, Inc. 52d3e633-13a2-cdcd-e063-6394a90ac189 2026-05-27 Warnings Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN Rite Aid Corporation 69ca781a-202e-4579-91e6-f32a22ccc22c 2026-05-27 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN Rite Aid Corporation 5883ebd4-8cf7-45f1-8c66-e87416835fcc 2026-05-27 Warnings Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN Rite Aid Corporation 99a76de3-166a-4902-b400-b262a4fa0ae8 2026-05-27 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN IBUPROFEN IBUPROFEN St. Mary's Medical Park Pharmacy 950c3ca7-4481-976f-e053-2995a90ad51e 2026-05-22 Boxed warning, Warnings, Adverse reactions Name fallback brand name: IBUPROFEN generic name: IBUPROFEN CHILDRENS IBUPROFEN IBUPROFEN Aurohealth LLC 7461e50d-bfa1-4627-b691-089636b979d2 2026-05-22 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN CVS Pharmacy 121b13c8-0b1a-4c48-9d57-3b53a9228d34 2026-05-22 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Berkley and Jensen Ibuprofen IBUPROFEN BJWC cda57e42-6106-46ee-82d1-479a692ee5bb 2026-05-21 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Grocery Outlet, Inc. 441d762d-9022-426a-e063-6294a90a5076 2026-05-21 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Salado Sales, Inc. 06bc4445-5c80-4dd3-b1bb-d9244f45f570 2026-05-20 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Cardinal Health 107, LLC 260f5862-d65d-4c34-bf53-26ca30806a67 2026-05-19 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN ibuprofen childrens IBUPROFEN Walgreen Company f67612e8-38f3-4d1c-889b-57995a2f9f66 2026-05-15 Warnings Name fallback generic name: IBUPROFEN good neighbor pharmacy ibuprofen IBUPROFEN Amerisource Bergen 085dcc1a-e4b0-4d08-9476-72275382d1a1 2026-05-15 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Meijer Distribution, Inc. 3e3a5366-535d-45fb-81af-c7d98ac20b11 2026-05-15 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.