IBUPROFEN
- Product NDC
- 50090-5160
- 11-digit product format
- 500905160
- Labeler code
- 50090
- Product ID
- 50090-5160_54a883db-4813-4b74-85c9-a7d132fc61a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IBUPROFEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090796
- Marketing category
- ANDA
- Marketing start
- 2015-12-30
- 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
- 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 | 50090-5160 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 50090-5160 | 50090-5160-0 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 50090-5160 | 50090-5160-1 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 50090-5160 | 50090-5160-3 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 50090-5160 | 50090-5160-4 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 50090-5160 | 50090-5160-8 | D | Discontinued by firm | 2026-08-17 |
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 | 50090-5160-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-5160-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-5160-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-5160-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-5160-8 | 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 | 50090-5160-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-5160-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-5160-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-5160-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-5160-8 | 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 | 50090-5160-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-5160-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-5160-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-5160-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-5160-8 | 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 | 50090-5160-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-5160-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-5160-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-5160-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-5160-8 | 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 | 50090-5160-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-5160-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-5160-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-5160-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-5160-8 | 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 | 50090-5160-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-5160-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-5160-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-5160-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-5160-8 | 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 | 50090-5160-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-5160-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-5160-4 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-5160-0 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-5160-8 | 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 | 50090-5160-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-5160-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-5160-4 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-5160-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-5160-8 | 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 | 50090-5160-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-5160-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-5160-4 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-5160-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-5160-8 | 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 | 50090-5160-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-5160-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-5160-4 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-5160-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-5160-8 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090796-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | |
| A090796-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | |
| A090796-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090796-001 | AB |
| A090796-002 | AB |
| A090796-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2010-12-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2010-12-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090796-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2010-12-21 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A090796-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090796-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090796-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090796-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090796-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090796-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090796-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090796-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090796-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090796-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090796-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090796-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090796-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090796-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090796-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090796-001 | AB | 1 | 1e350fbaab3a… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 50090-5160-0 | 2023-02-07 | IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS |
| 50090-5160-1 | 2023-02-07 | IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS |
| 50090-5160-3 | 2023-02-07 | IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS |
| 50090-5160-8 | 2023-02-07 | IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS |
| 50090-5160-0 | 2023-01-30 | IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS |
| 50090-5160-1 | 2023-01-30 | IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS |
| 50090-5160-3 | 2023-01-30 | IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS |
| 50090-5160-8 | 2023-01-30 | IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-5160-1 | EA - Each | 50090-5160 | 207bb44b-dfe3-4077-ae04-ea77d78498e3 | 1 | 2022-12-07 |
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. | a7756b22-73cf-4262-aa8e-0577ddecd03b | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | 950c3ca7-4481-976f-e053-2995a90ad51e | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| IBUPROFEN | IBUPROFEN | St. Mary's Medical Park Pharmacy | 95830141-2439-9d45-e053-2995a90ae084 | 2026-05-01 | 090796 ANDA090796 | |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | a348a959-46bc-4ff6-8936-12866fc34a4b | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | c20f1f4d-59b3-6bbe-e053-2a95a90abaf1 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | dac07d8f-6b6f-20ab-e053-2a95a90af3ba | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | da6c72ad-009f-3d7f-e053-2995a90a68e9 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | QPharma, Inc. | f452d2c3-525f-4933-b146-92351d0ae44f | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | ce5b0429-bbe1-47a4-af5e-0159d3cfd2c3 | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| IBUPROFEN | IBUPROFEN | Direct Rx | d88d0544-57a7-4a82-e053-2a95a90a1945 | 2025-01-21 | 090796 ANDA090796 | |
| IBUPROFEN | IBUPROFEN | DIRECT RX | c3f30813-0848-6e8a-e053-2995a90a3dea | 2025-01-20 | 090796 ANDA090796 | |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb | 2025-01-13 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 701ee488-c57f-a82c-e053-2991aa0af403 | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| IBUPROFEN | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 9b02607a-6fab-5205-e053-2a95a90afa26 | 2025-01-02 | 090796 ANDA090796 | |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | b33caad1-8d40-16f2-e053-2a95a90a1b2d | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | Advanced Rx Pharmacy of Tennessee, LLC | bd1ca7af-d640-23fb-e053-2a95a90a8a98 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | Advanced Rx Pharmacy of Tennessee, LLC | f18b6a0a-e42f-083d-e053-2995a90a40e4 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | TIME CAP LABORATORIES, INC | ec3e8443-d742-4c25-8516-f0df4ebfccdc | 2024-11-21 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | MARKSANS PHARMA LIMITED | e54209c2-f726-440b-ac60-5a72710d2a9b | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | 19b06eaf-0d4c-2b4d-e063-6294a90a2eb9 | 2024-08-06 | Boxed warning, Warnings, Adverse reactions | 090796 ANDA090796 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-5160-0 | 50090516000 | 16 TABLET, FILM COATED in 1 BOTTLE (50090-5160-0) | 2020-09-21 | 0000-00-00 | No | No | Current |
| 50090-5160-1 | 50090516001 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5160-1) | 2020-09-21 | 0000-00-00 | No | No | Current |
| 50090-5160-3 | 50090516003 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-5160-3) | 2020-09-21 | 0000-00-00 | No | No | Current |
| 50090-5160-8 | 50090516008 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-5160-8) | 2020-09-21 | 0000-00-00 | No | No | Current |