Ibuprofen
- Product NDC
- 50436-0321
- Requested package NDC
- 50436-0321-2
- 11-digit product format
- 504360321
- Labeler code
- 50436
- Product ID
- 50436-0321_799c662c-30bf-4859-9f90-97ab32371696
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA091625
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 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 package | package | 50436-0321 | 50436-0321-2 | I | Inactivated by FDA | 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… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091625-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | |
| A091625-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | |
| A091625-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091625-001 | AB |
| A091625-002 | AB |
| A091625-003 | 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 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 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 | A091625-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091625-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091625-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091625-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091625-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091625-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091625-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091625-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091625-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091625-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091625-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091625-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091625-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091625-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091625-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091625-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091625-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091625-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091625-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091625-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091625-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091625-001 | 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 | Related label |
|---|---|---|
| 50436-0321-1 | 2023-01-30 | IBUPROFEN Tablets, USP |
| 50436-0321-2 | 2023-01-30 | IBUPROFEN Tablets, USP |
| 50436-0321-3 | 2023-01-30 | IBUPROFEN Tablets, USP |
| 50436-0321-4 | 2023-01-30 | IBUPROFEN Tablets, USP |
| 50436-0321-5 | 2023-01-30 | IBUPROFEN Tablets, USP |
| 50436-0321-6 | 2023-01-30 | IBUPROFEN Tablets, USP |
| 50436-0321-1 | 2021-08-24 | IBUPROFEN Tablets, USP |
| 50436-0321-2 | 2021-08-24 | IBUPROFEN Tablets, USP |
| 50436-0321-3 | 2021-08-24 | IBUPROFEN Tablets, USP |
| 50436-0321-4 | 2021-08-24 | IBUPROFEN Tablets, USP |
| 50436-0321-5 | 2021-08-24 | IBUPROFEN Tablets, USP |
| 50436-0321-6 | 2021-08-24 | IBUPROFEN Tablets, USP |
| 50436-0321-1 | 2021-01-29 | IBUPROFEN Tablets, USP |
| 50436-0321-2 | 2021-01-29 | IBUPROFEN Tablets, USP |
| 50436-0321-3 | 2021-01-29 | IBUPROFEN Tablets, USP |
| 50436-0321-4 | 2021-01-29 | IBUPROFEN Tablets, USP |
| 50436-0321-5 | 2021-01-29 | IBUPROFEN Tablets, USP |
| 50436-0321-6 | 2021-01-29 | IBUPROFEN Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-0321-1 | Ibuprofen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 12 | |
| 50436-0321-2 | Ibuprofen | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 12 | |
| 50436-0321-3 | Ibuprofen | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 12 | |
| 50436-0321-4 | Ibuprofen | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 12 | |
| 50436-0321-5 | Ibuprofen | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | 12 | |
| 50436-0321-6 | Ibuprofen | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-0321-1 | EA - Each | 50436-0321 | 1473e49e-033f-450e-8afe-ad1a766b9070 | 1 | 2017-09-11 |
| 50436-0321-2 | EA - Each | 50436-0321 | fa18be60-558c-4263-ab80-76b2a773e2c2 | 1 | 2017-09-11 |
| 50436-0321-3 | EA - Each | 50436-0321 | fd04fd57-707a-4edc-a37e-731da5cb4ef9 | 1 | 2017-09-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-0321 | IBUPROFEN TABLET, FILM COATED [UNIT DOSE SERVICES] | 12 | Legacy NDC, 6 package rows | 20210825_a4c74188-9af6-422c-abd9-087a8ab4b43a.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 | PD-Rx Pharmaceuticals, Inc. | d3a7ebef-f7ab-4b34-b62e-278a8deabf78 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | b81c6495-8b30-41ef-8a0f-4cbfd87f1eb4 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 57a1bf99-5aaf-432d-86ba-5f0e7cfab1a0 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | f1c88d74-09b0-4b14-baea-106fbbbc54bf | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | b6a6c940-daf6-4e0e-aefb-35cce87a9a55 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 421156d2-85dc-4680-b2b4-d15b67539e87 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 20078671-536f-4b0b-a079-f90ac186a670 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 1e6f3ce7-e8a3-40e8-8437-523ef5277b2e | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Unit Dose Solutions, Inc. | 5515661b-6373-2191-e063-6294a90a17e0 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | b40f39e4-a37c-4039-ae37-210c1c3c6235 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 51de1183-d226-4869-a00a-f6c74e126a39 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 25a94943-9acc-49c8-a4da-7e07bb2c35eb | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | ab80abe6-f7db-479b-e053-2a95a90a90e3 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Ascend Laboratories, LLC | 9ce036ef-a22d-4fca-9a62-1b10978f7b26 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 560e4e05-21e0-4b2a-ab2f-872b5dbb3901 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | QPharma Inc | fd8b82a7-96fe-8bf5-e053-6394a90a3935 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Granules Pharmaceuticals Inc. | 4aefcb3a-5dc8-b88e-e063-6294a90ac044 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| IBUPROFEN | IBUOROFEN | Direct_Rx | 90b8b80e-ab30-3590-e053-2a95a90a70ef | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Legacy Pharmaceutical Packaging, LLC | 5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197805 | ibuprofen 400 MG Oral Tablet | PSN | a4c74188-9af6-422c-abd9-087a8ab4b43a | 12 |
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | a4c74188-9af6-422c-abd9-087a8ab4b43a | 12 |
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | a4c74188-9af6-422c-abd9-087a8ab4b43a | 12 |
| 197805 | ibuprofen 400 MG Oral Tablet | SCD | a4c74188-9af6-422c-abd9-087a8ab4b43a | 12 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | a4c74188-9af6-422c-abd9-087a8ab4b43a | 12 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | a4c74188-9af6-422c-abd9-087a8ab4b43a | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50436-0321-2 | 50436032102 | 60 TABLET, FILM COATED in 1 BOTTLE (50436-0321-2) | 2016-08-01 | 0000-00-00 | No | No | Current |