Ibuprofen
- Product NDC
- 72789-200
- 11-digit product format
- 727890200
- Labeler code
- 72789
- Product ID
- 72789-200_3417f658-e09c-4667-e063-6394a90a7228
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2020-08-21
- 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 |
|---|---|---|---|---|---|---|---|
| A078329-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | |
| A078329-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | |
| A078329-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078329-001 | AB |
| A078329-002 | AB |
| A078329-003 | 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 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2009-02-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2009-02-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2009-02-05 | 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 | A078329-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078329-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078329-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078329-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078329-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078329-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078329-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078329-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078329-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078329-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078329-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078329-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078329-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078329-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078329-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078329-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078329-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078329-001 | 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 |
|---|---|
| 689dbbe8-4f85-48fe-8efc-fda81b60d37f | 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 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 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 |
|---|---|---|---|---|---|---|
| 72789-200-10 | Ibuprofen | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | 14 | |
| 72789-200-12 | Ibuprofen | 12 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 12 | 14 | |
| 72789-200-15 | Ibuprofen | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | 14 | |
| 72789-200-20 | Ibuprofen | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | 14 | |
| 72789-200-21 | Ibuprofen | 21 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 21 | 14 | |
| 72789-200-30 | Ibuprofen | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 14 | |
| 72789-200-40 | Ibuprofen | 40 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 40 | 14 | |
| 72789-200-60 | Ibuprofen | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | 14 | |
| 72789-200-90 | Ibuprofen | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | 14 | |
| 72789-200-93 | Ibuprofen | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72789-200-10 | EA - Each | 72789-200 | ce7e9320-7aac-436f-ae72-9b38cef18bd2 | 1 | 2021-11-09 |
| 72789-200-12 | EA - Each | 72789-200 | 52f085ba-0d3e-4f42-b4bb-b1eaf86f7817 | 1 | 2021-11-09 |
| 72789-200-15 | EA - Each | 72789-200 | 8f31bb2d-6cac-494c-940d-2dc6aad25d11 | 1 | 2021-11-09 |
| 72789-200-20 | EA - Each | 72789-200 | abeff9da-ff3e-4466-a39c-baaaa98e0dfc | 1 | 2021-11-09 |
| 72789-200-21 | EA - Each | 72789-200 | 06f83ff4-605f-4466-817d-dd915bd4bdbd | 1 | 2021-11-09 |
| 72789-200-30 | EA - Each | 72789-200 | 8b9f5fdb-0f00-4fbf-9e7f-65f282cfeac9 | 1 | 2021-09-07 |
| 72789-200-40 | EA - Each | 72789-200 | 3f38b69c-6109-4615-bb31-e2b9e25c7c16 | 1 | 2021-11-09 |
| 72789-200-60 | EA - Each | 72789-200 | c3575ce3-faae-41f5-bf69-6bb063b30fb7 | 1 | 2021-09-07 |
| 72789-200-90 | EA - Each | 72789-200 | 794b9e99-4a70-409e-8555-e9a4d5702bef | 1 | 2021-09-07 |
| 72789-200-93 | EA - Each | 72789-200 | f3943331-dc46-42ab-86b3-a617beea38b0 | 1 | 2021-11-09 |
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 | Aphena Pharma Solutions - Tennessee, LLC | 31f59d10-d821-2291-e063-6294a90ac518 | 2025-04-04 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 3140a614-c7ae-3062-e063-6394a90ad3d7 | 2025-03-26 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | SOLA Pharmaceuticals, LLC | b19b8c34-e0c1-4982-92fc-34dbe7384935 | 2024-12-02 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 1361b6d6-0443-460a-8446-41f63a1e28df | 2024-10-28 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 92efad86-31ae-78e5-e053-2995a90a0fda | 2024-07-03 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | a2160213-2a32-2044-e053-2995a90a21af | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 8c3dccbb-1084-cd09-e053-2a95a90ac12a | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 8cb93e5f-4ebc-24b7-e053-2a95a90a5a23 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 88795f0e-41b7-504e-e053-2995a90a3b9e | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Amneal Pharmaceuticals NY LLC | e07d989d-1b0e-4cc1-abf2-93c8b208a29a | 2023-12-30 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 7152b6ce-6113-4003-bf80-aa263be69392 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 400faee1-f662-470e-bcd6-7711dfaf9ba2 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 91723661-d0bb-4498-ac59-59bbdc334230 | 2022-01-27 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | 8813a8a4-ebbd-4204-88a3-600a92ea9170 | 2020-12-01 | Boxed warning, Warnings, Adverse reactions | 078329 ANDA078329 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 689dbbe8-4f85-48fe-8efc-fda81b60d37f | 14 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 689dbbe8-4f85-48fe-8efc-fda81b60d37f | 14 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72789-200-10 | 72789020010 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-10) | 2021-09-28 | 0000-00-00 | No | No | Current |
| 72789-200-12 | 72789020012 | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-12) | 2021-10-11 | 0000-00-00 | No | No | Current |
| 72789-200-15 | 72789020015 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-15) | 2021-09-21 | 0000-00-00 | No | No | Current |
| 72789-200-20 | 72789020020 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-20) | 2021-09-28 | 0000-00-00 | No | No | Current |
| 72789-200-21 | 72789020021 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-21) | 2021-09-28 | 0000-00-00 | No | No | Current |
| 72789-200-30 | 72789020030 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-30) | 2021-08-23 | 0000-00-00 | No | No | Current |
| 72789-200-40 | 72789020040 | 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-40) | 2021-09-28 | 0000-00-00 | No | No | Current |
| 72789-200-60 | 72789020060 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-60) | 2021-08-23 | 0000-00-00 | No | No | Current |
| 72789-200-90 | 72789020090 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-90) | 2021-08-23 | 0000-00-00 | No | No | Current |
| 72789-200-93 | 72789020093 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-93) | 2021-09-28 | 0000-00-00 | No | No | Current |