Ibuprofen
- Product NDC
- 50090-4230
- 11-digit product format
- 500904230
- Labeler code
- 50090
- Product ID
- 50090-4230_39dfd833-4e95-4e49-871f-40e0446ff886
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2017-04-15
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 600 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
- 2020-12-31
- 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 | 50090-4230 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 50090-4230 | 50090-4230-0 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50090-4230 | 50090-4230-1 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50090-4230 | 50090-4230-2 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50090-4230 | 50090-4230-3 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50090-4230 | 50090-4230-4 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50090-4230 | 50090-4230-5 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50090-4230 | 50090-4230-7 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50090-4230 | 50090-4230-8 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50090-4230 | 50090-4230-9 | I | Inactivated by FDA | 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 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4230-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-fb9f-0266-e053-dadaa90a7c1a | IBUPROFEN TABLETS |
| 50090-4230-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-fb9f-0266-e053-dadaa90a7c1a | IBUPROFEN TABLETS |
| 50090-4230-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-fb9f-0266-e053-dadaa90a7c1a | IBUPROFEN TABLETS |
| 50090-4230-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-fb9f-0266-e053-dadaa90a7c1a | IBUPROFEN TABLETS |
| 50090-4230-4 | 2023-01-30 | C162847 | 48780-1 | f386c649-fb9f-0266-e053-dadaa90a7c1a | IBUPROFEN TABLETS |
| 50090-4230-5 | 2023-01-30 | C162847 | 48780-1 | f386c649-fb9f-0266-e053-dadaa90a7c1a | IBUPROFEN TABLETS |
| 50090-4230-7 | 2023-01-30 | C162847 | 48780-1 | f386c649-fb9f-0266-e053-dadaa90a7c1a | IBUPROFEN TABLETS |
| 50090-4230-8 | 2023-01-30 | C162847 | 48780-1 | f386c649-fb9f-0266-e053-dadaa90a7c1a | IBUPROFEN TABLETS |
| 50090-4230-9 | 2023-01-30 | C162847 | 48780-1 | f386c649-fb9f-0266-e053-dadaa90a7c1a | IBUPROFEN TABLETS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4230-0 | Ibuprofen | 10 in 1 BOTTLE | TABLET | 10 | 1 | |
| 50090-4230-1 | Ibuprofen | 12 in 1 BOTTLE | TABLET | 12 | 1 | |
| 50090-4230-2 | Ibuprofen | 16 in 1 BOTTLE | TABLET | 16 | 1 | |
| 50090-4230-3 | Ibuprofen | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 50090-4230-4 | Ibuprofen | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 50090-4230-5 | Ibuprofen | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 50090-4230-7 | Ibuprofen | 40 in 1 BOTTLE | TABLET | 40 | 1 | |
| 50090-4230-8 | Ibuprofen | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 50090-4230-9 | Ibuprofen | 24 in 1 BOTTLE | TABLET | 24 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4230 | IBUPROFEN TABLET [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 9 package rows | 20190402_18069b35-7118-404e-a6c1-946f3c71164c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | 18069b35-7118-404e-a6c1-946f3c71164c | 1 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | 18069b35-7118-404e-a6c1-946f3c71164c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4230-0 | 50090423000 | 10 TABLET in 1 BOTTLE (50090-4230-0) | 10 tablet | 2019-03-27 | 0000-00-00 | No | No | Current |
| 50090-4230-1 | 50090423001 | 12 TABLET in 1 BOTTLE (50090-4230-1) | 12 tablet | 2019-03-27 | 0000-00-00 | No | No | Current |
| 50090-4230-2 | 50090423002 | 16 TABLET in 1 BOTTLE (50090-4230-2) | 16 tablet | 2019-03-27 | 0000-00-00 | No | No | Current |
| 50090-4230-3 | 50090423003 | 30 TABLET in 1 BOTTLE (50090-4230-3) | 30 tablet | 2019-03-27 | 0000-00-00 | No | No | Current |
| 50090-4230-4 | 50090423004 | 60 TABLET in 1 BOTTLE (50090-4230-4) | 60 tablet | 2019-03-27 | 0000-00-00 | No | No | Current |
| 50090-4230-5 | 50090423005 | 100 TABLET in 1 BOTTLE (50090-4230-5) | 100 tablet | 2019-03-27 | 0000-00-00 | No | No | Current |
| 50090-4230-7 | 50090423007 | 40 TABLET in 1 BOTTLE (50090-4230-7) | 40 tablet | 2019-03-27 | 0000-00-00 | No | No | Current |
| 50090-4230-8 | 50090423008 | 20 TABLET in 1 BOTTLE (50090-4230-8) | 20 tablet | 2019-03-27 | 0000-00-00 | No | No | Current |
| 50090-4230-9 | 50090423009 | 24 TABLET in 1 BOTTLE (50090-4230-9) | 24 tablet | 2019-03-27 | 0000-00-00 | No | No | Current |