Ibuprofen
- Product NDC
- 63187-980
- 11-digit product format
- 631870980
- Labeler code
- 63187
- Product ID
- 63187-980_35ff4860-111c-48cb-94c3-6601d892901a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA091625
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- Substance
- IBUPROFEN
- Active strength
- 600 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | caaa826d4ba7… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091625-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091625-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091625-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091625-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091625-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091625-003 | AB | 1 | caaa826d4ba7… |
| 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… |
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 | 600 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WK2XYI10QM | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 197806 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d2c7f045-e70c-4e2b-b2e0-d81a271d0a04 | Available on FDA.report |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63187-980-15 | Ibuprofen | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | 9 | |
| 63187-980-20 | Ibuprofen | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 9 | |
| 63187-980-21 | Ibuprofen | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | 9 | |
| 63187-980-28 | Ibuprofen | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | 9 | |
| 63187-980-30 | Ibuprofen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 9 | |
| 63187-980-40 | Ibuprofen | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | 9 | |
| 63187-980-42 | Ibuprofen | 42 in 1 BOTTLE | TABLET, FILM COATED | 42 | 9 | |
| 63187-980-50 | Ibuprofen | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 9 | |
| 63187-980-60 | Ibuprofen | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 9 | |
| 63187-980-90 | Ibuprofen | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-980-15 | EA - Each | 63187-980 | f1367d51-b7ca-4613-a98e-dbe45f9b8613 | 1 | 2023-04-07 |
| 63187-980-20 | EA - Each | 63187-980 | b82c6d76-6034-46df-bb3d-b4f794db3df3 | 1 | 2018-06-11 |
| 63187-980-21 | EA - Each | 63187-980 | 378ca956-6ec7-42d9-8fcf-eb258fd83aa6 | 1 | 2021-08-05 |
| 63187-980-28 | EA - Each | 63187-980 | e854799f-31f9-4220-a49b-9305d539faed | 1 | 2022-03-09 |
| 63187-980-30 | EA - Each | 63187-980 | c7c06d69-b165-461e-99a4-1ab81e2ef539 | 1 | 2018-06-11 |
| 63187-980-40 | EA - Each | 63187-980 | 35a0d36d-32bf-4b85-8f4f-4d3a6beaf49f | 1 | 2018-05-09 |
| 63187-980-42 | EA - Each | 63187-980 | 4bf1f469-5f48-4649-965b-b8a9f792bd63 | 1 | 2019-04-11 |
| 63187-980-50 | EA - Each | 63187-980 | 60c93a35-222c-412a-91a4-7650218d4a7a | 1 | 2022-08-04 |
| 63187-980-60 | EA - Each | 63187-980 | 392e0f4d-fc3d-4109-a34e-74ce55dd89d9 | 1 | 2023-08-08 |
| 63187-980-90 | EA - Each | 63187-980 | 34b88579-177f-4421-89e4-b4a56fcb9ee4 | 1 | 2020-01-03 |
DailyMed Dashboard NDC Coverage#
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 | Northwind Health Company, LLC | 2f12a20c-4293-d18a-e063-6294a90a3afc | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | f2a08223-a73a-5461-e053-2995a90a3bce | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | ab074ae8-5696-5327-e053-2a95a90a7ce3 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 894a5d14-e405-43ac-a5a2-0b4de5b28474 | 2025-09-11 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Advanced Rx of Tennessee, LLC | af9ac948-440c-5abf-e053-2995a90af2b5 | 2025-08-07 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Advanced Rx Pharmacy of Tennessee, LLC | c859cc7a-e13a-7df4-e053-2a95a90a47d6 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | d0198bdc-fe2b-4b09-8f78-9e5a7f6ae784 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 60f1c099-5fb5-47e8-b228-11de1ef40f4b | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | ffc953f7-ed92-4528-bb2f-72c634c119fa | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | EXELAN PHARMACEUTICALS, INC. | 362f934a-4382-43bc-bedd-65081286f1c9 | 2024-03-19 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | fd691a4a-8010-45e6-b3da-b26374792f24 | 2024-01-26 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 8553e29a-7f6f-4ff8-9991-836e619c504d | 2023-12-10 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | e4644cb5-7fae-456a-98d3-62ba521cd0b2 | 2023-09-12 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PharmPak, Inc. | b493bf76-1e8b-4e72-bef6-aca4efc69cbe | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PharmPak, Inc. | 4d95bccd-8280-4d03-a574-927669c7cda0 | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PharmPak, Inc. | bb6d0547-c113-42f9-8bf2-c227a55ab758 | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | d2c7f045-e70c-4e2b-b2e0-d81a271d0a04 | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 63187-980 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | 2dc3108f-d917-40c6-865d-c900cf055d1c | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | 444b2ea0-ec42-4bcf-b8d2-38b4b297ada0 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 4a86a190-da5d-4b7a-a05f-e3e7ccbfa603 | 2019-01-19 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | d2c7f045-e70c-4e2b-b2e0-d81a271d0a04 | 9 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | d2c7f045-e70c-4e2b-b2e0-d81a271d0a04 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63187-980-15 | 63187098015 | 15 TABLET, FILM COATED in 1 BOTTLE (63187-980-15) | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-980-20 | 63187098020 | 20 TABLET, FILM COATED in 1 BOTTLE (63187-980-20) | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-980-21 | 63187098021 | 21 TABLET, FILM COATED in 1 BOTTLE (63187-980-21) | 2021-06-23 | 0000-00-00 | No | No | Current |
| 63187-980-28 | 63187098028 | 28 TABLET, FILM COATED in 1 BOTTLE (63187-980-28) | 2022-02-08 | 0000-00-00 | No | No | Current |
| 63187-980-30 | 63187098030 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-980-30) | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-980-40 | 63187098040 | 40 TABLET, FILM COATED in 1 BOTTLE (63187-980-40) | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-980-42 | 63187098042 | 42 TABLET, FILM COATED in 1 BOTTLE (63187-980-42) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-980-50 | 63187098050 | 50 TABLET, FILM COATED in 1 BOTTLE (63187-980-50) | 2022-05-17 | 0000-00-00 | No | No | Current |
| 63187-980-60 | 63187098060 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-980-60) | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-980-90 | 63187098090 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-980-90) | 2018-02-01 | 0000-00-00 | No | No | Current |