Ibuprofen
- Product NDC
- 70518-1839
- Requested package NDC
- 70518-1839-0
- 11-digit product format
- 705181839
- Labeler code
- 70518
- Product ID
- 70518-1839_d4d9127f-b6e3-2c38-e053-2995a90a46f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078558
- Marketing category
- ANDA
- Marketing start
- 2019-01-31
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70518-1839 | 70518-1839-0 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078558-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | |
| A078558-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | |
| A078558-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078558-001 | AB |
| A078558-002 | AB |
| A078558-003 | 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 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2007-06-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2007-06-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078558-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2007-06-18 | 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 | A078558-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078558-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078558-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078558-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078558-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078558-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078558-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078558-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078558-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078558-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078558-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078558-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078558-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078558-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078558-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078558-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078558-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078558-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078558-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078558-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | Amneal Pharmaceuticals LLC | 17577b3b-e755-45d1-8b53-775d058578b2 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Cardinal Health 107, LLC | 0387bfaa-daca-48ec-b718-0216a848c16a | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | PHOENIX RX LLC | 40202c76-4275-88fd-e063-6394a90a07b2 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 334e40f3-6da4-ecbe-e063-6294a90a35bf | 2025-04-21 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | fc871659-ce41-1be6-e053-6294a90aa5e4 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | af9af7f4-6314-6217-e053-2995a90a5a0f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Amneal Pharmaceuticals of New York LLC | faebc392-0fd9-4c71-8471-beba10dda022 | 2024-07-29 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 1a02fa34-b5ae-7183-e063-6294a90a3ae4 | 2024-06-03 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | e90c573d-eb0f-45a5-94d1-efdd3d2b7a11 | 2024-01-16 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | fa99f5ec-0306-473b-827f-86cd0a7978ec | 2023-08-31 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | e4bb22bb-6df6-4016-a023-0b454df9fb0b | 2023-06-01 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | e23eb275-ce0c-40ec-b809-a48c5e46c7ec | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 078558 ANDA078558 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-1839-0 | 70518183900 | 30 TABLET in 1 BLISTER PACK (70518-1839-0) | 30 tablet | 2019-01-31 | 0000-00-00 | No | No | Current |