Fenofibrate
- Product NDC
- 0115-0533
- 11-digit product format
- 001150533
- Labeler code
- 0115
- Product ID
- 0115-0533_4faa7be9-6cb4-4192-a287-555ad2ba3cbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA075868
- Marketing category
- ANDA
- Marketing start
- 2010-02-01
- Marketing end
- 0000-00-00
- Substance
- FENOFIBRATE
- Active strength
- 200 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-0533-01 | Fenofibrate | 100 in 1 BOTTLE | CAPSULE | 100 | | 48 |
| 0115-0533-02 | Fenofibrate | 500 in 1 BOTTLE | CAPSULE | 500 | | 48 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-0533 | FENOFIBRATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 48 | Legacy NDC, 2 package rows | 20221208_bfc6668c-3f69-4dd3-bc19-0d26c23dd04c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0115-0533-01 | 00115053301 | 100 CAPSULE in 1 BOTTLE (0115-0533-01) | 100 capsule | 2010-02-01 | 0000-00-00 | No | No | Current |
| 0115-0533-02 | 00115053302 | 500 CAPSULE in 1 BOTTLE (0115-0533-02) | 500 capsule | 2010-02-01 | 0000-00-00 | No | No | Current |