Ibuprofen
- Product NDC
- 50090-2548
- 11-digit product format
- 500902548
- Labeler code
- 50090
- Product ID
- 50090-2548_f0c4785a-b0fb-439c-b323-1fa74881a338
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA091625
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- 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
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 | 50090-2548 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 50090-2548 | 50090-2548-0 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50090-2548 | 50090-2548-1 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50090-2548 | 50090-2548-2 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50090-2548 | 50090-2548-3 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50090-2548 | 50090-2548-4 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50090-2548 | 50090-2548-5 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50090-2548 | 50090-2548-7 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50090-2548 | 50090-2548-8 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 50090-2548 | 50090-2548-9 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091625-001 | IBUPROFEN | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | |
| A091625-002 | IBUPROFEN | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | |
| A091625-003 | IBUPROFEN | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091625-001 | AB |
| A091625-002 | AB |
| A091625-003 | 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 | A091625-001 | IBUPROFEN | 400MG | TABLET / ORAL | AB | 2015-09-15 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A091625-002 | IBUPROFEN | 600MG | TABLET / ORAL | AB | 2015-09-15 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A091625-003 | IBUPROFEN | 800MG | TABLET / ORAL | AB | 2015-09-15 | 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 | A091625-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091625-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A091625-003 | 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 | PD-Rx Pharmaceuticals, Inc. | d3a7ebef-f7ab-4b34-b62e-278a8deabf78 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | b81c6495-8b30-41ef-8a0f-4cbfd87f1eb4 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 57a1bf99-5aaf-432d-86ba-5f0e7cfab1a0 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | f1c88d74-09b0-4b14-baea-106fbbbc54bf | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | b6a6c940-daf6-4e0e-aefb-35cce87a9a55 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 421156d2-85dc-4680-b2b4-d15b67539e87 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 20078671-536f-4b0b-a079-f90ac186a670 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 1e6f3ce7-e8a3-40e8-8437-523ef5277b2e | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Unit Dose Solutions, Inc. | 5515661b-6373-2191-e063-6294a90a17e0 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | b40f39e4-a37c-4039-ae37-210c1c3c6235 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 51de1183-d226-4869-a00a-f6c74e126a39 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 50090-2548 |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 25a94943-9acc-49c8-a4da-7e07bb2c35eb | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Northwind Health Company, LLC | ab80abe6-f7db-479b-e053-2a95a90a90e3 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Ascend Laboratories, LLC | 9ce036ef-a22d-4fca-9a62-1b10978f7b26 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 560e4e05-21e0-4b2a-ab2f-872b5dbb3901 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | QPharma Inc | fd8b82a7-96fe-8bf5-e053-6394a90a3935 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Granules Pharmaceuticals Inc. | 4aefcb3a-5dc8-b88e-e063-6294a90ac044 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| IBUPROFEN | IBUOROFEN | Direct_Rx | 90b8b80e-ab30-3590-e053-2a95a90a70ef | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
| Ibuprofen | IBUPROFEN | Legacy Pharmaceutical Packaging, LLC | 5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 091625 ANDA091625 |
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2548-0 | Ibuprofen | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 55 | |
| 50090-2548-1 | Ibuprofen | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | 55 | |
| 50090-2548-2 | Ibuprofen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 55 | |
| 50090-2548-3 | Ibuprofen | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | 55 | |
| 50090-2548-4 | Ibuprofen | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 55 | |
| 50090-2548-5 | Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 55 | |
| 50090-2548-7 | Ibuprofen | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | 55 | |
| 50090-2548-8 | Ibuprofen | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | 55 | |
| 50090-2548-9 | Ibuprofen | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | 55 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2548-0 | EA - Each | 50090-2548 | e435607f-4032-4e20-90d3-9fc3b0c3a267 | 1 | 2019-03-12 |
| 50090-2548-1 | EA - Each | 50090-2548 | fa5111fe-da49-4b28-a85e-5a2e20d7e9aa | 1 | 2018-11-06 |
| 50090-2548-2 | EA - Each | 50090-2548 | 2ba9b2e8-68b0-4c8e-b7e5-a48112b3de3a | 1 | 2018-11-06 |
| 50090-2548-3 | EA - Each | 50090-2548 | 595709a9-4c95-4260-97a3-ea186a98cae7 | 1 | 2018-11-06 |
| 50090-2548-4 | EA - Each | 50090-2548 | 822c441c-f9a8-40a5-befe-fb114ec08e8f | 1 | 2018-11-06 |
| 50090-2548-5 | EA - Each | 50090-2548 | 232f78e6-c7b3-42fb-b404-f69c5cea0144 | 1 | 2018-11-06 |
| 50090-2548-7 | EA - Each | 50090-2548 | 6163dabd-1d5d-43cf-94df-44cd55c9e3ad | 1 | 2018-11-06 |
| 50090-2548-8 | EA - Each | 50090-2548 | c38b67fb-6732-4635-8ccc-b36509b12723 | 1 | 2018-11-06 |
| 50090-2548-9 | EA - Each | 50090-2548 | a9696a99-1e42-4b07-8912-9cf87a421ab9 | 1 | 2019-03-12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2548 | IBUPROFEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 55 | Current NDC, Legacy NDC, 9 package rows | 20250510_51de1183-d226-4869-a00a-f6c74e126a39.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197805 | ibuprofen 400 MG Oral Tablet | PSN | 51de1183-d226-4869-a00a-f6c74e126a39 | 55 |
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | 51de1183-d226-4869-a00a-f6c74e126a39 | 55 |
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 51de1183-d226-4869-a00a-f6c74e126a39 | 55 |
| 197805 | ibuprofen 400 MG Oral Tablet | SCD | 51de1183-d226-4869-a00a-f6c74e126a39 | 55 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | 51de1183-d226-4869-a00a-f6c74e126a39 | 55 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 51de1183-d226-4869-a00a-f6c74e126a39 | 55 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-2548-0 | 50090254800 | 10 TABLET, FILM COATED in 1 BOTTLE (50090-2548-0) | 2017-02-13 | 0000-00-00 | No | No | Current |
| 50090-2548-1 | 50090254801 | 15 TABLET, FILM COATED in 1 BOTTLE (50090-2548-1) | 2016-12-08 | 0000-00-00 | No | No | Current |
| 50090-2548-2 | 50090254802 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-2548-2) | 2016-10-20 | 0000-00-00 | No | No | Current |
| 50090-2548-3 | 50090254803 | 45 TABLET, FILM COATED in 1 BOTTLE (50090-2548-3) | 2017-01-06 | 0000-00-00 | No | No | Current |
| 50090-2548-4 | 50090254804 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-2548-4) | 2016-10-27 | 0000-00-00 | No | No | Current |
| 50090-2548-5 | 50090254805 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-2548-5) | 2016-10-24 | 0000-00-00 | No | No | Current |
| 50090-2548-7 | 50090254807 | 21 TABLET, FILM COATED in 1 BOTTLE (50090-2548-7) | 2016-10-26 | 0000-00-00 | No | No | Current |
| 50090-2548-8 | 50090254808 | 12 TABLET, FILM COATED in 1 BOTTLE (50090-2548-8) | 2016-12-08 | 0000-00-00 | No | No | Current |
| 50090-2548-9 | 50090254809 | 40 TABLET, FILM COATED in 1 BOTTLE (50090-2548-9) | 2016-11-01 | 0000-00-00 | No | No | Current |