Ibuprofen
- Product NDC
- 83059-0165
- Requested package NDC
- 83059-0165-3
- 11-digit product format
- 830590165
- Labeler code
- 83059
- Product ID
- 83059-0165_575dbcb4-5dfe-a2b6-e063-6294a90a24b5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Shield Pharmaceuticals Corp
- Application
- ANDA207095
- Marketing category
- ANDA
- Marketing start
- 2026-07-24
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207095-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | ||
| A207095-002 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | bb7c543d1eb4… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IBUPROFEN | 200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WK2XYI10QM | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 310965 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1ca722bb-940e-4b3e-9561-d87e2feb1ff8 | Available on FDA.report |
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 | Shield Pharmaceuticals Corp | 216e5600-56b4-44b0-88b7-69adfb245802 | 2026-08-06 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Shield Pharmaceuticals Corp | 1ca722bb-940e-4b3e-9561-d87e2feb1ff8 | 2026-07-24 | Warnings | 207095 ANDA207095 83059-0165-3 83059-0165 83059016503 |
| Ibuprofen | IBUPROFEN | Shield Pharmaceuticals Corp | fc6c29b4-f1b3-4cfe-8c96-564d083be39c | 2026-07-24 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | PROSTAT FIRST AID | 3bca27b4-3df6-b7d1-e063-6394a90ac6af | 2025-08-07 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Trifecta Pharmaceuticals USA LLC | 37299475-e2f3-de26-e063-6394a90ad62d | 2025-06-09 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Allegiant Health | 2ea039d6-f522-4103-a1f9-5b80a3b12a27 | 2025-04-14 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Trifecta Pharmaceuticals USA LLC | 09972806-e064-238d-e063-6394a90a7434 | 2024-12-31 | Warnings | 207095 ANDA207095 |
| Ibuprofen 200mg | IBUPROFEN 200MG | Allegiant Health | 265e2b47-d14a-45a8-adc0-7214e2057103 | 2024-09-30 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Trifecta Pharmaceuticals USA LLC | 114b5e23-6cd7-41d8-e063-6294a90aa0f0 | 2024-06-12 | Warnings | 207095 ANDA207095 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83059-0165-3 | 83059016503 | 1 BOTTLE in 1 CARTON (83059-0165-3) / 30 TABLET, COATED in 1 BOTTLE | 1 bottle | 2026-07-24 | No | No | Current |