ibuprofen
- Product NDC
- 68788-8183
- Requested package NDC
- 68788-8183-4
- 11-digit product format
- 687888183
- Labeler code
- 68788
- Product ID
- 68788-8183_b6a670e1-9a98-4742-b73c-b61105a07f5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2022-04-29
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 68788-8183 | 68788-8183-4 | D | Discontinued by firm | 2026-08-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A202413-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2016-11-23 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A202413-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2016-11-23 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A202413-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2016-11-23 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A202413-004 | IBUPROFEN | 300MG | TABLET / ORAL | 2024-07-05 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A202413-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A202413-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A202413-003 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 2572ed69-d5a7-4513-a202-aca3230e7ec5 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 656658cc-8cf0-42b6-af4f-4e3ab7648625 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | c0156053-add5-4bd5-b89f-f90df2e73be4 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 3a38add6-a114-4e18-836c-3bfc727db231 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Redpharm Drug | 5302291e-4816-8495-e063-6394a90a9cc0 | 2026-05-30 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 404df13d-4ada-4324-9eed-e21f5d5043a4 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | ST. MARY'S MEDICAL PARK PHARMACY | 4e67aef4-c3ac-232a-e063-6394a90a3a85 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 886c974c-0d32-4a1b-8f54-40c2c12efa45 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 2e0f74a5-b8f3-fc81-e063-6394a90a647a | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Proficient Rx LP | ab2f1a30-611b-41b6-9baf-6a82305da845 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 4b34b58b-2cf7-9aa8-e063-6294a90a0658 | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 0170876a-d8cd-4a2d-8397-db2acdf72ffb | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | 70e191ef-8fad-49eb-9850-fceea119e92f | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | b84ea215-e61d-4c00-8a34-d47c4080779b | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Coupler LLC | 4831785a-cde2-79a2-e063-6294a90a9a40 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | AiPing Pharmaceutical, Inc. | 3e131710-2579-446e-8076-f602ecea813f | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Chartwell RX, LLC | 39f2664f-6c0a-4726-85d7-4227530d4a49 | 2025-12-10 | Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Redpharm Drug | 44f278ac-6bf9-6aef-e063-6394a90a0bb6 | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Redpharm Drug | 44f5743f-8c98-dc4d-e063-6294a90a6dfa | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
| Ibuprofen | IBUPROFEN | Redpharm Drug | 44f609dd-c868-493f-e063-6294a90a7138 | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | 202413 ANDA202413 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8183-1 | EA - Each | 68788-8183 | 437d6c30-5463-4735-b45d-cc8b33d6a455 | 1 | 2022-07-06 |
| 68788-8183-2 | EA - Each | 68788-8183 | 71c79ac2-d4d7-48a2-9282-269f44ba29bf | 1 | 2022-07-06 |
| 68788-8183-3 | EA - Each | 68788-8183 | 01c63b47-58de-4dad-b6f7-2bd828a45530 | 1 | 2022-07-06 |
| 68788-8183-4 | EA - Each | 68788-8183 | 14b618ba-b8a3-4449-b9ca-56b2f3b5c0cf | 1 | 2022-07-06 |
| 68788-8183-5 | EA - Each | 68788-8183 | 155e70c3-5ad6-4313-8a34-3d0726461c7c | 1 | 2022-07-06 |
| 68788-8183-6 | EA - Each | 68788-8183 | 1c1c8d06-43e0-449e-865b-a86eace6ffbf | 1 | 2022-07-06 |
| 68788-8183-7 | EA - Each | 68788-8183 | 49314f3e-3ddf-4062-a3bf-201115c4e39d | 1 | 2022-07-06 |
| 68788-8183-8 | EA - Each | 68788-8183 | e5f0d54f-3aca-4080-b18f-36f19ee67057 | 1 | 2022-07-06 |
| 68788-8183-9 | EA - Each | 68788-8183 | 0e070542-83a1-48bb-ba6e-8314cd67e859 | 1 | 2022-07-06 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-8183-4 | 68788818304 | 14 TABLET, FILM COATED in 1 BOTTLE (68788-8183-4) | 2022-04-29 | 0000-00-00 | No | No | Current |