Ibuprofen
- Product NDC
- 42254-034
- 11-digit product format
- 422540034
- Labeler code
- 42254
- Product ID
- 42254-034_940f3140-fe00-4297-ba81-f49bc3a3ace0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA078558
- Marketing category
- ANDA
- Marketing start
- 2009-11-23
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42254-034-20 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d64-c013-e053-90daa90a1393 | Ibuprofen Tablets, USP |
| 42254-034-21 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d64-c013-e053-90daa90a1393 | Ibuprofen Tablets, USP |
| 42254-034-30 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d64-c013-e053-90daa90a1393 | Ibuprofen Tablets, USP |
| 42254-034-60 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d64-c013-e053-90daa90a1393 | Ibuprofen Tablets, USP |
| 42254-034-90 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d64-c013-e053-90daa90a1393 | Ibuprofen Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-034-20 | Ibuprofen | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 42254-034-21 | Ibuprofen | 21 in 1 BOTTLE | TABLET | 21 | 1 | |
| 42254-034-30 | Ibuprofen | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 42254-034-60 | Ibuprofen | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 42254-034-90 | Ibuprofen | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197805 | ibuprofen 400 MG Oral Tablet | PSN | 940f3140-fe00-4297-ba81-f49bc3a3ace0 | 1 |
| 197806 | ibuprofen 600 MG Oral Tablet | PSN | 940f3140-fe00-4297-ba81-f49bc3a3ace0 | 1 |
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 940f3140-fe00-4297-ba81-f49bc3a3ace0 | 1 |
| 197805 | ibuprofen 400 MG Oral Tablet | SCD | 940f3140-fe00-4297-ba81-f49bc3a3ace0 | 1 |
| 197806 | ibuprofen 600 MG Oral Tablet | SCD | 940f3140-fe00-4297-ba81-f49bc3a3ace0 | 1 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 940f3140-fe00-4297-ba81-f49bc3a3ace0 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 42254-034-20 | 42254003420 | 20 in 1 BOTTLE | Historical |
| 42254-034-21 | 42254003421 | 21 in 1 BOTTLE | Historical |
| 42254-034-30 | 42254003430 | 30 in 1 BOTTLE | Historical |
| 42254-034-60 | 42254003460 | 60 in 1 BOTTLE | Historical |
| 42254-034-90 | 42254003490 | 90 in 1 BOTTLE | Historical |