Ibuprofen
- Product NDC
- 11788-003
- Requested package NDC
- 11788-003-10
- 11-digit product format
- 117880003
- Labeler code
- 11788
- Product ID
- 11788-003_59b694b2-6f22-f17b-e053-2991aa0ab8b7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AiPing Pharmaceutical, Inc.
- Application
- ANDA207095
- Marketing category
- ANDA
- Marketing start
- 2017-05-08
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 package | package | 11788-003 | 11788-003-10 | I | Inactivated by FDA | 2026-08-10 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207095-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | ||
| A207095-002 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 87673890dc5c… |
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 |
|---|---|---|---|---|---|
| 11788-003-00 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6672-111a-e063-dadaa90a10e2 | IBUPROFEN CAPLETS, USP 200mg |
| 11788-003-07 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f963-111a-e063-dadaa90a10e2 | Ibuprofen Caplets, USP 200 mg |
| 11788-003-10 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f963-111a-e063-dadaa90a10e2 | Ibuprofen Caplets, USP 200 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11788-003-07 | Ibuprofen | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 8 | |
| 11788-003-07 | Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 8 | |
| 11788-003-10 | Ibuprofen | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 8 | |
| 11788-003-00 | Ibuprofen | 50864 in 1 CARTON | TABLET, FILM COATED | 50864 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11788-003 | IBUPROFEN TABLET, FILM COATED [AIPING PHARMACEUTICAL, INC.] | 8 | Legacy NDC, 3 package rows | 20171019_e7c6d352-a460-4bf8-a92f-5865249bd22b.zip |
| 11788-003 | IBUPROFEN TABLET, FILM COATED [AIPING PHARMACEUTICAL, INC.] | 3 | Legacy NDC, 1 package rows | 20170927_67bc0f56-fe1a-4796-9fdd-44dfd4906a6f.zip |
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 | Shield Pharmaceuticals Corp | 216e5600-56b4-44b0-88b7-69adfb245802 | 2026-08-06 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Shield Pharmaceuticals Corp | 1ca722bb-940e-4b3e-9561-d87e2feb1ff8 | 2026-07-24 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Shield Pharmaceuticals Corp | fc6c29b4-f1b3-4cfe-8c96-564d083be39c | 2026-07-24 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | PROSTAT FIRST AID | 3bca27b4-3df6-b7d1-e063-6394a90ac6af | 2025-08-07 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Trifecta Pharmaceuticals USA LLC | 37299475-e2f3-de26-e063-6394a90ad62d | 2025-06-09 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Allegiant Health | 2ea039d6-f522-4103-a1f9-5b80a3b12a27 | 2025-04-14 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Trifecta Pharmaceuticals USA LLC | 09972806-e064-238d-e063-6394a90a7434 | 2024-12-31 | Warnings | 207095 ANDA207095 |
| Ibuprofen 200mg | IBUPROFEN 200MG | Allegiant Health | 265e2b47-d14a-45a8-adc0-7214e2057103 | 2024-09-30 | Warnings | 207095 ANDA207095 |
| Ibuprofen | IBUPROFEN | Trifecta Pharmaceuticals USA LLC | 114b5e23-6cd7-41d8-e063-6294a90aa0f0 | 2024-06-12 | Warnings | 207095 ANDA207095 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310965 | ibuprofen 200 MG Oral Tablet | PSN | e7c6d352-a460-4bf8-a92f-5865249bd22b | 8 |
| 310965 | ibuprofen 200 MG Oral Tablet | SCD | e7c6d352-a460-4bf8-a92f-5865249bd22b | 8 |
| 310965 | ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet | SY | e7c6d352-a460-4bf8-a92f-5865249bd22b | 8 |
| 310965 | ibuprofen 200 MG Oral Tablet | PSN | 67bc0f56-fe1a-4796-9fdd-44dfd4906a6f | 3 |
| 310965 | ibuprofen 200 MG Oral Tablet | SCD | 67bc0f56-fe1a-4796-9fdd-44dfd4906a6f | 3 |
| 310965 | ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet | SY | 67bc0f56-fe1a-4796-9fdd-44dfd4906a6f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11788-003-10 | 11788000310 | 1000 TABLET, FILM COATED in 1 BOTTLE (11788-003-10) | 2017-05-08 | 0000-00-00 | No | No | Current |