FENOFIBRATE
- Product NDC
- 35356-916
- 11-digit product format
- 353560916
- Labeler code
- 35356
- Product ID
- 35356-916_ffcb1baf-f8e3-4ab3-838b-bf40750e7ac9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA076509
- Marketing category
- ANDA
- Marketing start
- 2010-02-01
- Marketing end
- 0000-00-00
- Substance
- FENOFIBRATE
- Active strength
- 160 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 35356-916-30 | 2025-01-15 | C162847 | 48780-1 | ba0f9c33-267a-a910-e053-dadaa90a0b85 | 07913d99-c2d8-4078-9f1f-acad2a83b3d8 |
| 35356-916-60 | 2025-01-15 | C162847 | 48780-1 | ba0f9c33-267a-a910-e053-dadaa90a0b85 | 07913d99-c2d8-4078-9f1f-acad2a83b3d8 |
| 35356-916-90 | 2025-01-15 | C162847 | 48780-1 | ba0f9c33-267a-a910-e053-dadaa90a0b85 | 07913d99-c2d8-4078-9f1f-acad2a83b3d8 |
| 35356-916-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-267a-a910-e053-dadaa90a0b85 | 07913d99-c2d8-4078-9f1f-acad2a83b3d8 |
| 35356-916-60 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-267a-a910-e053-dadaa90a0b85 | 07913d99-c2d8-4078-9f1f-acad2a83b3d8 |
| 35356-916-90 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-267a-a910-e053-dadaa90a0b85 | 07913d99-c2d8-4078-9f1f-acad2a83b3d8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35356-916-30 | EA - Each | 35356-916 | c644e9c1-2aff-47f0-9b43-5164887ba034 | 1 | 2015-10-02 |