Ibuprofen
- Product NDC
- 59556-876
- 11-digit product format
- 595560876
- Labeler code
- 59556
- Product ID
- 59556-876_4cd77671-6091-4bd0-9a34-8650001b9fdd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Strides Pharma Inc
- Application
- ANDA211666
- Marketing category
- ANDA
- Marketing start
- 2022-02-21
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 59556-876 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 59556-876 | 59556-876-01 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 59556-876 | 59556-876-72 | D | Discontinued by firm | 2026-10-05 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211666-001 | IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 |
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 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 87673890dc5c… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211666-001 | IBUPROFEN | 100MG/5ML | SUSPENSION / ORAL | 2021-02-22 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59556-876-01 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 4 | |
| 59556-876-01 | Ibuprofen | 240 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 240 | 4 | |
| 59556-876-72 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | 4 | |
| 59556-876-72 | Ibuprofen | 120 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 120 | 4 |
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 | Sun Pharmaceutical Industries, Inc. | 9de61620-6750-4fb6-89a4-fe451ab8d99f | 2026-07-15 | Warnings | 211666 ANDA211666 |
| ibuprofen | IBUPROFEN | A-S Medication Solutions | 7d4ba8be-df59-4a21-8850-8a59bf72b604 | 2025-09-11 | Warnings | 211666 ANDA211666 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197803 | ibuprofen 100 MG in 5 mL Oral Suspension | PSN | c3c600dd-6eec-4304-868e-9642de5e1dac | 4 |
| 197803 | ibuprofen 20 MG/ML Oral Suspension | SCD | c3c600dd-6eec-4304-868e-9642de5e1dac | 4 |
| 197803 | ibuprofen 100 MG per 5 ML Oral Suspension | SY | c3c600dd-6eec-4304-868e-9642de5e1dac | 4 |
| 197803 | ibuprofen 200 MG per 10 ML Oral Suspension | SY | c3c600dd-6eec-4304-868e-9642de5e1dac | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59556-876-01 | 59556087601 | 1 in 1 CARTON | Historical | ||||
| 59556-876-72 | 59556087672 | 1 BOTTLE, PLASTIC in 1 CARTON (59556-876-72) > 120 mL in 1 BOTTLE, PLASTIC | 2022-02-21 | 0000-00-00 | No | No | Current |