Ibuprofen
- Product NDC
- 42291-441
- Requested package NDC
- 42291-441-95
- 11-digit product format
- 422910441
- Labeler code
- 42291
- Product ID
- 42291-441_d57cc4c3-b774-5ff8-e053-2995a90afadd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2020-09-03
- 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
- 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 | 42291-441 | 42291-441-95 | D | Discontinued by firm | 2026-08-11 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078329-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | |
| A078329-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | |
| A078329-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078329-001 | AB |
| A078329-002 | AB |
| A078329-003 | 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 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 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 | A078329-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078329-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078329-001 | AB | 1 | 8072bd15b7f6… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42291-441-95 | 2024-10-08 | C162847 | 48780-1 | 0191ceaa-61ba-198a-e063-dbdaa90aec3e | Ibuprofen Tablets, USP Rx Only |
| 42291-441-95 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-61ba-198a-e063-dbdaa90aec3e | Ibuprofen Tablets, USP Rx Only |
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 | 88dd304f-1c64-08e3-e053-2a95a90a596f | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | ST. MARY'S MEDICAL PARK PHARMACY | 88dda062-2b9c-3632-e053-2a95a90a1431 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | 60c731c6-4dc4-490a-8469-0b7e58e563a1 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 1ebf94fb-76b6-4c01-be1b-575062827545 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 0550fa2f-f25e-4abb-b10e-a3d05bdb3217 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | c38a03fa-6b9a-4737-a848-063ca5c580b9 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 8dba0ed8-feef-23a5-e053-2995a90aaff8 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Strides Pharma Science Limited | a266a3c6-932f-476f-ae93-48a785c92286 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 86577bf3-51c6-88e2-e053-2991aa0ac741 | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Direct_Rx | 40071818-5bf0-095b-e063-6294a90ad58a | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | 06710aef-2631-4925-8e9e-33bae84b5912 | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | 3b9fdc48-c071-4e2c-e063-6294a90a679f | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Asclemed USA, Inc. | d7ed42c4-371c-4a54-ab15-0630656f0427 | 2025-08-02 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NCS HealthCare of KY, LLC dba Vangard Labs | ab11e142-9e11-4ce4-9671-7e4fe53ffe92 | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NCS HealthCare of KY, LLC dba Vangard Labs | f1842893-7a34-4f77-8231-55fb0c98b22b | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 3732defa-67c2-4b84-8a84-4bbc27b6cb24 | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 689dbbe8-4f85-48fe-8efc-fda81b60d37f | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 09621787-9a5c-4abf-9ccd-d6f8d581738f | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 42b92fd7-468c-4fb8-9ff0-31296735df4c | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 7942cc53-1268-4e5f-8db0-f0b3524bb744 | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42291-441-95 | 42291044195 | 500 TABLET, FILM COATED in 1 BOTTLE (42291-441-95) | 2020-09-03 | 0000-00-00 | No | No | Current |