IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2026-03-12
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 22
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:59:36
Label at a glance#
ProductIBUPROFEN
Active ingredientIBUPROFEN
Label structure5 sections
Contacts and useful links#
Label contents#
Full prescribing information#
ibuprofen tablets 400 mg - 600 mg- 800 mg medguide
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
(724) 465-8762
HOW SUPPLIED
600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500
HOW SUPPLIED SECTION
Ibuprofen tablets are available in the following strength:
800 mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on one side and plain on other side)
NDC: 70518-0005-00
NDC: 70518-0005-01
NDC: 70518-0005-02
NDC: 70518-0005-03
NDC: 70518-0005-04
NDC: 70518-0005-05
NDC: 70518-0005-06
PACKAGING: 21 in 1 BLISTER PACK
PACKAGING: 14 in 1 BLISTER PACK
PACKAGING: 30 in 1 BLISTER PACK
PACKAGING: 10 in 1 BLISTER PACK
PACKAGING: 90 in 1 BOTTLE PLASTIC
PACKAGING: 30 in 1 BOTTLE PLASTIC
PACKAGING: 30 in 1 BLISTER PACK
“Preserve in well-closed containers”
Store at 20 ° to 25°C (68°to 77°F) [See USP Controlled Room Temperature].
Rx only
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
HOW SUPPLIED
Ibuprofen tablets are available in the following strength:
800 mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on one side and plain on other side)
NDC: 70518-0005-00
NDC: 70518-0005-01
NDC: 70518-0005-02
NDC: 70518-0005-03
NDC: 70518-0005-04
NDC: 70518-0005-05
NDC: 70518-0005-06
PACKAGING: 21 in 1 BLISTER PACK
PACKAGING: 14 in 1 BLISTER PACK
PACKAGING: 30 in 1 BLISTER PACK
PACKAGING: 10 in 1 BLISTER PACK
PACKAGING: 90 in 1 BOTTLE PLASTIC
PACKAGING: 30 in 1 BOTTLE PLASTIC
PACKAGING: 30 in 1 BLISTER PACK
“Preserve in well-closed containers”
Store at 20 ° to 25°C (68°to 77°F) [See USP Controlled Room Temperature].
Rx only
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
PRINCIPAL DISPLAY PANEL
DRUG: IBUPROFEN
GENERIC: IBUPROFEN
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-0005-0
NDC: 70518-0005-1
NDC: 70518-0005-2
NDC: 70518-0005-3
NDC: 70518-0005-4
NDC: 70518-0005-5
NDC: 70518-0005-6
COLOR: white
SHAPE: CAPSULE
SCORE: No score
SIZE: 19 mm
IMPRINT: 123
PACKAGING: 21 in 1 BLISTER PACK
PACKAGING: 14 in 1 BLISTER PACK
PACKAGING: 30 in 1 BLISTER PACK
PACKAGING: 10 in 1 BLISTER PACK
PACKAGING: 90 in 1 BOTTLE PLASTIC
PACKAGING: 30 in 1 BOTTLE PLASTIC
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- IBUPROFEN 800mg in 1
INACTIVE INGREDIENT(S):
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL
- STARCH, PREGELATINIZED CORN
- TALC
- TITANIUM DIOXIDE
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70518-0005-6 | EA - Each | 70518-0005 | 528a562e-58c9-4097-b59f-8fcbf89ec7e3 | 1 | 2025-12-16 |
| 49483-604-01 | EA - Each | 49483-604 | 4c978774-cbdd-4eda-a974-dfea4b1a3110 | 1 | 2016-01-13 |
| 49483-604-50 | EA - Each | 49483-604 | 3bc46c7c-6ff6-423b-9ef0-88aec4a6d297 | 1 | 2016-01-13 |
Products#
Every source-derived product name is available through these pages.
- IBUPROFEN
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL
- STARCH, PREGELATINIZED CORN
- TALC
- TITANIUM DIOXIDE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70518-0005 | 70518-0005-0, 70518-0005-1, 70518-0005-2, 70518-0005-3, 70518-0005-4, 70518-0005-5, 70518-0005-6 |
| 49483-604 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POLYVINYL ALCOHOL | 532B59J990 | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 20 | 2026-01-07 | monthly-update | 2026-06-03 17:53:53 |
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 |
|---|---|---|---|---|---|---|
| 50fea5dc-db71-6024-e063-6394a90a7dee | 9dfc752f-3f66-4c39-bfa8-db6de9a9a9bf | 2026-05-04 | 9dfc752f-3f66-4c39-bfa8-db6de9a9a9bf | |||
| Ibuprofen | IBUPROFEN | TIME CAP LABORATORIES, INC | ec3e8443-d742-4c25-8516-f0df4ebfccdc | 2024-11-21 | Boxed warning, Warnings, Adverse reactions | 49483-604 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.