Ibuprofen
- Product NDC
- 58657-681
- Requested package NDC
- 58657-681-50
- 11-digit product format
- 586570681
- Labeler code
- 58657
- Product ID
- 58657-681_9d53122c-b5f8-1472-e053-2a95a90a971c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2017-04-15
- 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
- 2021-12-31
- 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 | 58657-681 | 58657-681-50 | D | Discontinued by firm | 2026-08-03 |
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 |
|---|---|---|---|---|---|---|---|
| A202413-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-004 | IBUPROFEN | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202413-001 | AB |
| A202413-002 | AB |
| A202413-003 | 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 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202413-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202413-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202413-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202413-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202413-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202413-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202413-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202413-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202413-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202413-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202413-001 | 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58657-681-01 | EA - Each | 58657-681 | 15ed7097-bd1c-43b2-bfeb-35c5f65d3de1 | 1 | 2017-05-04 |
| 58657-681-50 | EA - Each | 58657-681 | 59a9bd9a-5cad-4928-a535-e5f9fb896720 | 1 | 2017-05-04 |
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 | REMEDYREPACK INC. | 2572ed69-d5a7-4513-a202-aca3230e7ec5 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 656658cc-8cf0-42b6-af4f-4e3ab7648625 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | c0156053-add5-4bd5-b89f-f90df2e73be4 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 3a38add6-a114-4e18-836c-3bfc727db231 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Redpharm Drug | 5302291e-4816-8495-e063-6394a90a9cc0 | 2026-05-30 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 404df13d-4ada-4324-9eed-e21f5d5043a4 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | ST. MARY'S MEDICAL PARK PHARMACY | 4e67aef4-c3ac-232a-e063-6394a90a3a85 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 886c974c-0d32-4a1b-8f54-40c2c12efa45 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 2e0f74a5-b8f3-fc81-e063-6394a90a647a | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | ab2f1a30-611b-41b6-9baf-6a82305da845 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 4b34b58b-2cf7-9aa8-e063-6294a90a0658 | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 0170876a-d8cd-4a2d-8397-db2acdf72ffb | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | 70e191ef-8fad-49eb-9850-fceea119e92f | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | b84ea215-e61d-4c00-8a34-d47c4080779b | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Coupler LLC | 4831785a-cde2-79a2-e063-6294a90a9a40 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | AiPing Pharmaceutical, Inc. | 3e131710-2579-446e-8076-f602ecea813f | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Chartwell RX, LLC | 39f2664f-6c0a-4726-85d7-4227530d4a49 | 2025-12-10 | Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Redpharm Drug | 44f278ac-6bf9-6aef-e063-6394a90a0bb6 | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Redpharm Drug | 44f5743f-8c98-dc4d-e063-6294a90a6dfa | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Redpharm Drug | 44f609dd-c868-493f-e063-6294a90a7138 | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | 888ea2f1-4f64-7d10-e053-2a95a90ad8cb | 3 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | 888ea2f1-4f64-7d10-e053-2a95a90ad8cb | 3 |
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | 18069b35-7118-404e-a6c1-946f3c71164c | 1 |
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | b98774f5-5b87-44ae-b0e1-6dacc122b178 | 1 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | 18069b35-7118-404e-a6c1-946f3c71164c | 1 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | b98774f5-5b87-44ae-b0e1-6dacc122b178 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58657-681-50 | 58657068150 | 500 TABLET in 1 BOTTLE (58657-681-50) | 500 tablet | 2017-04-15 | 0000-00-00 | No | No | Current |