Ibuprofen
- Product NDC
- 51655-035
- 11-digit product format
- 516550035
- Labeler code
- 51655
- Product ID
- 51655-035_bee0fc29-5017-472e-8a0a-b11bee969d17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Pharmaceuticals, LLC
- Application
- ANDA078558
- Marketing category
- ANDA
- Marketing start
- 2014-10-28
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 600 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
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 51655-035-20 | 2026-01-10 | C162847 | 48780-1 | 9d75b9d1-202b-f424-e053-dadaa90a57ce | Ibuprofen |
| 51655-035-50 | 2026-01-10 | C162847 | 48780-1 | 9d75b9d1-202b-f424-e053-dadaa90a57ce | Ibuprofen |
| 51655-035-52 | 2026-01-10 | C162847 | 48780-1 | 9d75b9d1-202b-f424-e053-dadaa90a57ce | Ibuprofen |
| 51655-035-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-202b-f424-e053-dadaa90a57ce | Ibuprofen |
| 51655-035-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-202b-f424-e053-dadaa90a57ce | Ibuprofen |
| 51655-035-52 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-202b-f424-e053-dadaa90a57ce | Ibuprofen |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 3 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 3 |