Ibuprofen
- Product NDC
- 58657-680
- 11-digit product format
- 586570680
- Labeler code
- 58657
- Product ID
- 58657-680_9d53122c-b5f8-1472-e053-2a95a90a971c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2017-04-15
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 product | product | 58657-680 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 58657-680 | 58657-680-01 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 58657-680 | 58657-680-50 | 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 |
|---|---|---|---|---|---|
| 58657-680-01 | EA - Each | 58657-680 | 17122841-8e6c-44b3-b449-23c4c706a321 | 1 | 2017-05-04 |
| 58657-680-50 | EA - Each | 58657-680 | 357e6dc7-708d-4c8f-b1ca-1e110035e8aa | 1 | 2017-05-04 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58657-680-01 | 58657068001 | 100 TABLET in 1 BOTTLE (58657-680-01) | 100 tablet | 2017-04-15 | 0000-00-00 | No | No | Current |
| 58657-680-50 | 58657068050 | 500 TABLET in 1 BOTTLE (58657-680-50) | 500 tablet | 2017-04-15 | 0000-00-00 | No | No | Current |