IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Effective date
- 2024-05-24
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:02:00
Label at a glance#
Label contents#
Full prescribing information#
HOW SUPPLIED
400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side)
- Bottles of 20 NDC 68788-7745-02
Bottles of 28 NDC 68788-7745-08
Bottles of 30 NDC 68788-7745-03
Bottles of 50 NDC 68788-7745-05
Bottles of 60 NDC 68788-7745-06
Bottles of 90 NDC 68788-7745-09
Bottles of 100 NDC 68788-7745-01
Repackaged by Preferred Pharmaceuticals, Inc.
400mg Ibuprofen
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-7745 | IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] | 5 | Legacy NDC | 20240526_20fda75a-c560-428b-b9fd-c12e97df4a74.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7745-1 | EA - Each | 68788-7745 | c041319d-ec57-487b-96ef-18154bf32620 | 1 | 2020-09-14 |
| 68788-7745-2 | EA - Each | 68788-7745 | 700668c5-122f-4b14-92a9-f32801f0d89a | 1 | 2020-09-14 |
| 68788-7745-3 | EA - Each | 68788-7745 | 15723172-f1a9-4e5a-bbb1-489fc1d0e766 | 1 | 2020-09-14 |
| 68788-7745-5 | EA - Each | 68788-7745 | 075377fe-a233-4471-9a8e-27be179ae7f8 | 1 | 2020-09-14 |
| 68788-7745-6 | EA - Each | 68788-7745 | 71f58420-cca5-4bd7-8801-89768f55d88f | 1 | 2020-09-14 |
| 68788-7745-8 | EA - Each | 68788-7745 | 623e8fd8-2c50-42bc-8207-5516522213f5 | 1 | 2020-09-14 |
| 68788-7745-9 | EA - Each | 68788-7745 | 489b743c-bafa-482f-aded-f6e227f4e78d | 1 | 2020-09-14 |
| 49483-602-01 | EA - Each | 49483-602 | 2fcf2aef-f364-4616-9d83-3fd90e8572d1 | 1 | 2016-01-13 |
| 49483-602-50 | EA - Each | 49483-602 | 047d18b6-f1fd-488e-89cf-926de1700cd4 | 1 | 2016-01-13 |
Products#
Every source-derived product name is available through these pages.
- IBUPROFEN
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- STARCH, CORN
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68788-7745 | 68788-7745-2, 68788-7745-8, 68788-7745-3, 68788-7745-5, 68788-7745-6, 68788-7745-9, 68788-7745-1 |
| 49483-602 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090796-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | |
| A090796-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | |
| A090796-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090796-001 | AB |
| A090796-002 | AB |
| A090796-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090796-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090796-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090796-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090796-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090796-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090796-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-001 | AB | 1 | 301d65b070ca… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2032b7fb-2c25-42e1-b85d-94babfd7273e | 20fda75a-c560-428b-b9fd-c12e97df4a74 | 2025-07-02 | 20fda75a-c560-428b-b9fd-c12e97df4a74 | |||
| Ibuprofen | IBUPROFEN | TIME CAP LABORATORIES, INC | ec3e8443-d742-4c25-8516-f0df4ebfccdc | 2024-11-21 | Boxed warning, Warnings, Adverse reactions | 49483-602 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

