Ibuprofen
- Product NDC
- 42291-337
- 11-digit product format
- 422910337
- Labeler code
- 42291
- Product ID
- 42291-337_a5771a01-4e19-a874-e053-2a95a90a11a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE, Inc.
- Application
- ANDA078558
- Marketing category
- ANDA
- Marketing start
- 2013-01-24
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 400 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|
| 42291-337-30 | EA - Each | 42291-337 | 564c5e7e-16e7-4d08-8ae0-9d6734926036 | 1 | 2016-02-04 |
| 42291-337-50 | EA - Each | 42291-337 | d9664a29-561a-4b96-8f0f-26f94d33ac64 | 1 | 2013-03-03 |
| 42291-337-60 | EA - Each | 42291-337 | 79f670e9-39c7-4400-87f9-d20badf6389e | 1 | 2017-03-06 |
| 42291-337-90 | EA - Each | 42291-337 | ae933823-b036-4218-b5bd-bdc145408ca2 | 1 | 2015-06-09 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197805 | ibuprofen 400 MG Oral Tablet | PSN | 9fb5c365-be2b-49eb-bc0c-417d83913e3e | 1 |
| 197805 | ibuprofen 400 MG Oral Tablet | SCD | 9fb5c365-be2b-49eb-bc0c-417d83913e3e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42291-337-50 | 42291033750 | 500 TABLET in 1 BOTTLE (42291-337-50) | 500 tablet | 2013-01-24 | 0000-00-00 | No | No | Current |