Ibuprofen
- Product NDC
- 50090-5438
- 11-digit product format
- 500905438
- Labeler code
- 50090
- Product ID
- 50090-5438_87c699a3-9d8a-4f2f-aac8-17240e2b8f9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA213794
- Marketing category
- ANDA
- Marketing start
- 2020-05-08
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 600 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
- 2022-12-31
- 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 product | product | 50090-5438 | I | Inactivated by FDA | 2026-08-10 | ||
| excluded package | package | 50090-5438 | 50090-5438-0 | I | Inactivated by FDA | 2026-08-10 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-5438-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-5438-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-5438-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-5438-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-5438-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-5438-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-5438-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-5438-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-5438-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-5438-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-5438-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-5438-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-5438-0 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-5438-0 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-5438-0 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213794-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | |
| A213794-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | |
| A213794-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213794-001 | AB |
| A213794-002 | AB |
| A213794-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213794-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2020-05-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213794-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2020-05-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213794-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2020-05-08 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213794-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213794-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213794-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213794-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213794-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213794-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213794-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213794-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213794-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213794-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213794-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213794-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213794-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213794-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213794-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213794-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213794-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213794-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213794-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213794-001 | AB | 1 | 8072bd15b7f6… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-5438-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-b2f3-0266-e053-dadaa90a7c1a | Ibuprofen Tablets, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-5438-0 | Ibuprofen | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-5438 | IBUPROFEN TABLET [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 1 package rows | 20210602_f64f9385-701d-440d-a53b-06267b454f10.zip |
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 | St. Mary's Medical Park Pharmacy | 0a98cce4-f5c0-12a8-e063-6294a90a4e7e | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | 34a9b94f-93ba-4a7c-92eb-d0b4b530d887 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | HAWAII REPACK, INC. | 6239818c-747d-4cbb-9b41-27ca8bbce41b | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Sportpharm LLC | cef04ae4-e78a-454d-bb66-84b1d348c106 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Unit Dose Solutions, Inc. | 5515e80f-7513-b425-e063-6294a90aa542 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 2fa4bfc8-386c-433b-bc46-24fc8ec1bca1 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | ec6b2df4-2f4f-4601-8b53-0542664e0bd9 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | bdc3f482-6fba-4420-9118-0f5cb7744e97 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | 13fd4401-1821-4f2b-a44e-96aa2fa75b5c | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | 25d9f5fc-4d95-4018-add8-ba696b6079b2 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 05ce8e8e-0b25-061e-e063-6394a90a2e92 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Coupler LLC | 50766a3d-1a22-be14-e063-6294a90a0ed2 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | NorthStar Rx LLC | aeee629b-255c-40d8-8e95-779aec00f723 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | Direct_Rx | 1aa11b52-1aca-9219-e063-6294a90a470f | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | f24582be-8d70-4848-bd54-e55fa28f394f | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | e5db46f3-043b-40ac-a89b-c90bd562e7b4 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 3db0c659-cc43-45dc-8442-bc89093d94d7 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | f60445d3-807e-0bbf-e053-2995a90a1299 | 2025-10-30 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 8d5f7d2a-af48-4d47-8bf5-48f01c092d24 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 4b75bd6f-5455-4237-991c-eacc0fdcf709 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | 213794 ANDA213794 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | f64f9385-701d-440d-a53b-06267b454f10 | 1 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | f64f9385-701d-440d-a53b-06267b454f10 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-5438-0 | 50090543800 | 30 TABLET in 1 BOTTLE (50090-5438-0) | 30 tablet | 2021-01-18 | 0000-00-00 | No | No | Current |