Fenofibrate
- Product NDC
- 35561-346
- 11-digit product format
- 355610346
- Labeler code
- 35561
- Product ID
- 35561-346_5097ee14-8bcd-10bb-e063-6394a90aa196
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bostal LLC
- Application
- ANDA207805
- Marketing category
- ANDA
- Marketing start
- 2017-11-17
- Substance
- FENOFIBRATE
- Active strength
- 134 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fenofibrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRATE | 134 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 200311, 310288, 310289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35561-346-11 | Fenofibrate | 90 in 1 BOTTLE | CAPSULE | 90 | | 10 |
| 35561-346-12 | Fenofibrate | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 35561-346-13 | Fenofibrate | 500 in 1 BOTTLE | CAPSULE | 500 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35561-346 | FENOFIBRATE CAPSULE [AUSTARPHARMA, LLC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20230126_a5bc232c-ff27-f8b6-e053-2995a90ad399.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 |
|---|
| 35561-346-11 | 35561034611 | 90 CAPSULE in 1 BOTTLE (35561-346-11) | 90 capsule | 2017-11-17 | 0000-00-00 | No | No | Current |
| 35561-346-12 | 35561034612 | 100 CAPSULE in 1 BOTTLE (35561-346-12) | 100 capsule | 2020-11-20 | 0000-00-00 | No | No | Current |
| 35561-346-13 | 35561034613 | 500 CAPSULE in 1 BOTTLE (35561-346-13) | 500 capsule | 2020-11-20 | | No | No | Historical |