Ibuprofen
- Product NDC
- 73614-201
- 11-digit product format
- 736140201
- Labeler code
- 73614
- Product ID
- 73614-201_2dcbe4bb-fb23-e827-e063-6394a90acf9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Brisk Pharmaceuticals
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2024-05-23
- Substance
- IBUPROFEN
- Active strength
- 800 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202413-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | |
| A202413-004 | IBUPROFEN | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202413-001 | AB |
| A202413-002 | AB |
| A202413-003 | 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 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202413-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202413-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202413-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202413-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202413-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202413-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202413-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202413-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202413-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202413-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202413-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202413-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202413-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202413-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202413-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202413-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202413-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202413-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202413-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202413-001 | 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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| IBUPROFEN | 800 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WK2XYI10QM | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 197807 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2dcbe4bb-fb24-e827-e063-6394a90acf9f | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73614-201-03 | ClindaCare | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 800 mg | 1 |
| 73614-201-03 | Ibuprofen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 | |
| 73614-201-03 | Orapaz | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 800 mg | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 73614-201 | CLINDACARE (CLINDAMYCIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE) KIT [BRISK PHARMACEUTICALS] | 1 | Current NDC | 20250215_2df8a89c-38df-c63b-e063-6394a90aaa36.zip |
| 73614-201 | IBUPROFEN TABLET, FILM COATED [BRISK PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20250213_2dcbe4bb-fb24-e827-e063-6394a90acf9f.zip |
| 73614-201 | ORAPAZ (CEPHALEXIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE) KIT [BRISK PHARMACEUTICALS] | 1 | Current NDC | 20250214_2de0b332-58a3-0bb4-e063-6394a90a1a45.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 | A-S Medication Solutions | 0ce79e85-0b8b-436e-b895-ea5c02eaf4ba | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 8d41cc03-dec6-4949-b7c1-7deb2897e2c4 | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | 43ac478c-43db-4136-8fee-4a43b09681e5 | 2024-10-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Asclemed USA, Inc. | ca81671d-1ea8-4c67-802f-adb3a2f087cc | 2024-09-08 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 214e3b3e-87b9-9ff5-e063-6394a90ae96a | 2024-09-04 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309114 | cephalexin 500 MG Oral Capsule | PSN | 2de0b332-58a3-0bb4-e063-6394a90a1a45 | 1 |
| 834127 | chlorhexidine gluconate 0.12 % Oral Rinse | PSN | 2df8a89c-38df-c63b-e063-6394a90aaa36 | 1 |
| 834127 | chlorhexidine gluconate 0.12 % Oral Rinse | PSN | 2de0b332-58a3-0bb4-e063-6394a90a1a45 | 1 |
| 197518 | clindamycin HCl 150 MG Oral Capsule | PSN | 2df8a89c-38df-c63b-e063-6394a90aaa36 | 1 |
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 2dcbe4bb-fb24-e827-e063-6394a90acf9f | 1 |
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 2df8a89c-38df-c63b-e063-6394a90aaa36 | 1 |
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 2de0b332-58a3-0bb4-e063-6394a90a1a45 | 1 |
| 309114 | cephalexin 500 MG Oral Capsule | SCD | 2de0b332-58a3-0bb4-e063-6394a90a1a45 | 1 |
| 834127 | chlorhexidine gluconate 1.2 MG/ML Mouthwash | SCD | 2de0b332-58a3-0bb4-e063-6394a90a1a45 | 1 |
| 834127 | chlorhexidine gluconate 1.2 MG/ML Mouthwash | SCD | 2df8a89c-38df-c63b-e063-6394a90aaa36 | 1 |
| 197518 | clindamycin 150 MG Oral Capsule | SCD | 2df8a89c-38df-c63b-e063-6394a90aaa36 | 1 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 2de0b332-58a3-0bb4-e063-6394a90a1a45 | 1 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 2df8a89c-38df-c63b-e063-6394a90aaa36 | 1 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 2dcbe4bb-fb24-e827-e063-6394a90acf9f | 1 |
| 309114 | cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule | SY | 2de0b332-58a3-0bb4-e063-6394a90a1a45 | 1 |
| 834127 | chlorhexidine gluconate 0.12 % Mouthwash | SY | 2de0b332-58a3-0bb4-e063-6394a90a1a45 | 1 |
| 834127 | chlorhexidine gluconate 0.12 % Mouthwash | SY | 2df8a89c-38df-c63b-e063-6394a90aaa36 | 1 |
| 834127 | chlorhexidine gluconate 0.12 % Oral Rinse | SY | 2df8a89c-38df-c63b-e063-6394a90aaa36 | 1 |
| 834127 | chlorhexidine gluconate 0.12 % Oral Rinse | SY | 2de0b332-58a3-0bb4-e063-6394a90a1a45 | 1 |
| 197518 | clindamycin (as clindamycin HCl) 150 MG Oral Capsule | SY | 2df8a89c-38df-c63b-e063-6394a90aaa36 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 73614-201-03 | 73614020103 | 30 TABLET, FILM COATED in 1 BOTTLE (73614-201-03) | 2025-02-10 | No | No | Current |