IBU
- Product NDC
- 67296-0877
- 11-digit product format
- 672960877
- Labeler code
- 67296
- Product ID
- 67296-0877_d60cee35-956a-6c59-e053-2a95a90a16a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IBU
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RedPharm Drug, Inc.
- Application
- ANDA075682
- Marketing category
- ANDA
- Marketing start
- 2008-11-20
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|---|---|---|---|---|
| 67296-0877-1 | 2024-07-11 | C162847 | 48780-1 | 1030e365-13b4-111a-e063-dadaa90a10e2 | 4d9f6f02-ff9d-6aa3-e054-00144ff8d46c |
| 67296-0877-2 | 2024-07-11 | C162847 | 48780-1 | 1030e365-13b4-111a-e063-dadaa90a10e2 | 4d9f6f02-ff9d-6aa3-e054-00144ff8d46c |
| 67296-0877-3 | 2024-07-11 | C162847 | 48780-1 | 1030e365-13b4-111a-e063-dadaa90a10e2 | 4d9f6f02-ff9d-6aa3-e054-00144ff8d46c |
| 67296-0877-6 | 2024-07-11 | C162847 | 48780-1 | 1030e365-13b4-111a-e063-dadaa90a10e2 | 4d9f6f02-ff9d-6aa3-e054-00144ff8d46c |
| 67296-0877-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-13b4-111a-e063-dadaa90a10e2 | 4d9f6f02-ff9d-6aa3-e054-00144ff8d46c |
| 67296-0877-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-13b4-111a-e063-dadaa90a10e2 | 4d9f6f02-ff9d-6aa3-e054-00144ff8d46c |
| 67296-0877-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-13b4-111a-e063-dadaa90a10e2 | 4d9f6f02-ff9d-6aa3-e054-00144ff8d46c |
| 67296-0877-6 | 2024-01-30 | C162847 | 48780-1 | 1030e365-13b4-111a-e063-dadaa90a10e2 | 4d9f6f02-ff9d-6aa3-e054-00144ff8d46c |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-0877-1 | IBU | 10 in 1 BOTTLE | TABLET | 10 | 8 | |
| 67296-0877-2 | IBU | 20 in 1 BOTTLE | TABLET | 20 | 8 | |
| 67296-0877-3 | IBU | 30 in 1 BOTTLE | TABLET | 30 | 8 | |
| 67296-0877-6 | IBU | 60 in 1 BOTTLE | TABLET | 60 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67296-0877 | IBU TABLET [REDPHARM DRUG, INC.] | 8 | Legacy NDC, 4 package rows | 20240712_4d9f6f02-ff9d-6aa3-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197807 | ibuprofen 800 MG Oral Tablet | PSN | 4d9f6f02-ff9d-6aa3-e054-00144ff8d46c | 8 |
| 197807 | ibuprofen 800 MG Oral Tablet | SCD | 4d9f6f02-ff9d-6aa3-e054-00144ff8d46c | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67296-0877-1 | 67296087701 | 10 TABLET in 1 BOTTLE (67296-0877-1) | 10 tablet | 2008-11-20 | 0000-00-00 | No | No | Current |
| 67296-0877-2 | 67296087702 | 20 TABLET in 1 BOTTLE (67296-0877-2) | 20 tablet | 2008-11-20 | 0000-00-00 | No | No | Current |
| 67296-0877-3 | 67296087703 | 30 TABLET in 1 BOTTLE (67296-0877-3) | 30 tablet | 2008-11-20 | 0000-00-00 | No | No | Current |
| 67296-0877-6 | 67296087706 | 60 TABLET in 1 BOTTLE (67296-0877-6) | 60 tablet | 2008-11-20 | 0000-00-00 | No | No | Current |