fenofibrate
- Product NDC
- 68071-3114
- 11-digit product format
- 680713114
- Labeler code
- 68071
- Product ID
- 68071-3114_bb13437d-35f4-fdff-e053-2995a90aff8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA090715
- Marketing category
- ANDA
- Marketing start
- 2014-09-23
- Marketing end
- 0000-00-00
- Substance
- FENOFIBRATE
- Active strength
- 145 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-3114-2 | 2024-08-15 | C162847 | 48780-1 | ba0f9c33-225e-a910-e053-dadaa90a0b85 | 4a6498fa-4a05-47a3-e054-00144ff8d46c |
| 68071-3114-3 | 2024-08-15 | C162847 | 48780-1 | ba0f9c33-225e-a910-e053-dadaa90a0b85 | 4a6498fa-4a05-47a3-e054-00144ff8d46c |
| 68071-3114-2 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-225e-a910-e053-dadaa90a0b85 | 4a6498fa-4a05-47a3-e054-00144ff8d46c |
| 68071-3114-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-225e-a910-e053-dadaa90a0b85 | 4a6498fa-4a05-47a3-e054-00144ff8d46c |
| 68071-3114-2 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-225e-a910-e053-dadaa90a0b85 | 4a6498fa-4a05-47a3-e054-00144ff8d46c |
| 68071-3114-3 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-225e-a910-e053-dadaa90a0b85 | 4a6498fa-4a05-47a3-e054-00144ff8d46c |
| 68071-3114-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-225e-a910-e053-dadaa90a0b85 | 4a6498fa-4a05-47a3-e054-00144ff8d46c |
| 68071-3114-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-225e-a910-e053-dadaa90a0b85 | 4a6498fa-4a05-47a3-e054-00144ff8d46c |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-3114-2 | 68071311402 | 20 TABLET in 1 BOTTLE (68071-3114-2) | 20 tablet | 2017-03-10 | 0000-00-00 | No | No | Current |
| 68071-3114-3 | 68071311403 | 30 TABLET in 1 BOTTLE (68071-3114-3) | 30 tablet | 2017-03-10 | 0000-00-00 | No | No | Current |