Ibuprofen
- Product NDC
- 58657-682
- 11-digit product format
- 586570682
- Labeler code
- 58657
- Product ID
- 58657-682_9d53122c-b5f8-1472-e053-2a95a90a971c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2017-04-15
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 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 |
|---|---|---|---|---|---|
| 58657-682-01 | EA - Each | 58657-682 | 20a65f63-28f7-4690-954a-30b1fa458edb | 1 | 2017-05-04 |
| 58657-682-50 | EA - Each | 58657-682 | 61b617d3-3f3f-4a91-9173-14c3418cdb0c | 1 | 2017-05-04 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 6857aded-5389-5dc1-e053-2a91aa0a744c | 5 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 6857aded-5389-5dc1-e053-2a91aa0a744c | 5 |
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 888f4079-56d0-f7c5-e053-2995a90a0f36 | 3 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 888f4079-56d0-f7c5-e053-2995a90a0f36 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58657-682-01 | 58657068201 | 100 TABLET in 1 BOTTLE (58657-682-01) | 100 tablet | 2017-04-15 | 0000-00-00 | No | No | Current |
| 58657-682-50 | 58657068250 | 500 TABLET in 1 BOTTLE (58657-682-50) | 500 tablet | 2017-04-15 | 0000-00-00 | No | No | Current |