sunmark ibuprofen
- Product NDC
- 49348-706
- 11-digit product format
- 493480706
- Labeler code
- 49348
- Product ID
- 49348-706_e56971b6-6be1-44c0-9979-a05b7320c8f1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Strategic Sourcing Services LLC
- Application
- ANDA072096
- Marketing category
- ANDA
- Marketing start
- 2003-06-24
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 200 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#
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 | 49348-706 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 49348-706 | 49348-706-01 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 49348-706 | 49348-706-04 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 49348-706 | 49348-706-09 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 49348-706 | 49348-706-10 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 49348-706 | 49348-706-14 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 49348-706 | 49348-706-16 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 49348-706 | 49348-706-19 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 49348-706 | 49348-706-42 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 49348-706-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 49348-706-42 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 49348-706-16 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 49348-706-19 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 49348-706-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 49348-706-14 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 49348-706-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 49348-706-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 49348-706-42 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 49348-706-16 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 49348-706-19 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 49348-706-14 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 49348-706-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 49348-706-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 49348-706-42 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 49348-706-16 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 49348-706-19 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 49348-706-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 49348-706-42 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 49348-706-16 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 49348-706-19 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 49348-706-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 49348-706-42 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 49348-706-16 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 49348-706-19 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 49348-706-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 49348-706-42 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 49348-706-16 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 49348-706-19 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 49348-706-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 49348-706-42 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 49348-706-19 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 49348-706-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 49348-706-42 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 49348-706-19 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 49348-706-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 49348-706-42 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 49348-706-19 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 49348-706-42 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 49348-706-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 49348-706-19 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 49348-706-42 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 49348-706-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 49348-706-19 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 49348-706-42 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 49348-706-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 49348-706-19 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A072096-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 |
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 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | f41ea6bd6efb… |
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-706-04 | EA - Each | 49348-706 | 21b515d3-160d-489c-a39b-e9c86c825037 | 1 | 2012-07-24 |
| 49348-706-09 | EA - Each | 49348-706 | de7bce97-732e-48ab-8c88-ed87e333d521 | 1 | 2012-07-24 |
| 49348-706-10 | EA - Each | 49348-706 | a54e6c71-e058-4bb0-adfe-cf4861bfc0af | 1 | 2012-07-24 |
| 49348-706-14 | EA - Each | 49348-706 | f47b5da8-3a81-463b-b7c5-1db4f6841f10 | 1 | 2012-07-24 |
| 49348-706-16 | EA - Each | 49348-706 | 928da66d-6b7b-4a2a-9f7d-c5da71cf2980 | 1 | 2017-06-15 |
| 49348-706-19 | EA - Each | 49348-706 | 5b9bfac9-2b36-4bd1-a05c-faa62487e64d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 | Publix Super Markets Inc | 2dd98554-e434-4617-b789-6ecce7144988 | 2023-05-04 | Warnings | 072096 ANDA072096 |
| ibuprofen | IBUPROFEN | Proficient Rx LP | 4ee828df-873d-4379-9a17-a805d97dfe04 | 2023-04-01 | Warnings | 072096 ANDA072096 |
| betr pain relief | IBUPROFEN | Live Betr LLC | 1b709dce-5c71-45e6-b516-d510a0a8c25d | 2022-08-24 | Warnings | 072096 ANDA072096 |
| ibuprofen | IBUPROFEN | Proficient Rx LP | 798d33b0-5d7a-4445-8a51-2a3d336f744a | 2022-04-01 | Warnings | 072096 ANDA072096 |
| basic care ibuprofen | IBUPROFEN | Amazon.com Services LLC | 9bbbedb3-e0b2-4645-8105-98800096cfed | 2022-03-09 | Warnings | 072096 ANDA072096 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310965 | ibuprofen 200 MG Oral Tablet | PSN | 2542cbee-3aca-4a2d-b9f8-07a86b0b3a43 | 1 |
| 310965 | ibuprofen 200 MG Oral Tablet | SCD | 2542cbee-3aca-4a2d-b9f8-07a86b0b3a43 | 1 |
| 310965 | ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet | SY | 2542cbee-3aca-4a2d-b9f8-07a86b0b3a43 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49348-706-04 | 49348070604 | 1 BOTTLE in 1 CARTON (49348-706-04) > 24 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2003-08-11 | 0000-00-00 | No | No | Current |
| 49348-706-09 | 49348070609 | 1 BOTTLE in 1 CARTON (49348-706-09) > 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2003-06-24 | 0000-00-00 | No | No | Current |
| 49348-706-10 | 49348070610 | 1 BOTTLE in 1 CARTON (49348-706-10) > 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2003-08-11 | 0000-00-00 | No | No | Current |
| 49348-706-14 | 49348070614 | 500 TABLET, FILM COATED in 1 BOTTLE (49348-706-14) | 2003-08-21 | 0000-00-00 | No | No | Current | |
| 49348-706-16 | 49348070616 | 1000 TABLET, FILM COATED in 1 BOTTLE (49348-706-16) | 2017-04-12 | 0000-00-00 | No | No | Current |