Fenofibrate
- Product NDC
- 68382-269
- 11-digit product format
- 683820269
- Labeler code
- 68382
- Product ID
- 68382-269_ed00bf28-39be-4b5a-a500-33962219771b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc
- Application
- NDA021656
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-02-09
- Marketing end
- 0000-00-00
- Substance
- FENOFIBRATE
- Active strength
- 48 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [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 |
|---|---|---|---|
| 193bb7da-5c03-8f95-9048-23ef403846b0 | Product name | 3 | 20250616 |
| fa35fb9a-7146-716b-13c8-bc1f60030232 | Product name | 9 | 20250114 |
| cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07 | Product name | 8 | 20231212 |
| 53d5b6b7-785a-4500-9460-263c7f8424b8 | Product name | 5 | 20210105 |
| ed9d55d4-85bd-0ee7-5b4a-b705646a3a66 | Product name | 9 | 20200708 |
| 36a239c8-03fb-0083-81af-6c1afb195671 | Product name | 1 | 20140508 |
| a0296d70-ca85-018c-84e8-cf3f630976b7 | Product name | 1 | 20140508 |
| f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372a | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68382-269-16 | 2020-02-28 | C162847 | 48780-1 | 9d75b9d0-2425-f424-e053-dadaa90a57ce | 1c3696b1-23c1-2992-86a0-c0882b81048d |
| 68382-269-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2425-f424-e053-dadaa90a57ce | 1c3696b1-23c1-2992-86a0-c0882b81048d |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68382-269-16 | EA - Each | 68382-269 | 57eda2fb-6498-4510-991c-cc6280e0c860 | 1 | 2016-10-06 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 477562 | fenofibrate 48 MG Oral Tablet | PSN | ffe2b024-fc89-411a-b22d-acb976022dd4 | 8 |
| 477562 | fenofibrate 48 MG Oral Tablet | SCD | ffe2b024-fc89-411a-b22d-acb976022dd4 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68382-269-16 | 68382026916 | 90 TABLET in 1 BOTTLE (68382-269-16) | 90 tablet | 2016-02-09 | 0000-00-00 | No | No | Current |