Lipofen
- Product NDC
- 62559-306
- 11-digit product format
- 625590306
- Labeler code
- 62559
- Product ID
- 62559-306_52430d63-6866-481c-a1b3-e411809cadfd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA021612
- Marketing category
- NDA
- Marketing start
- 2021-09-24
- Substance
- FENOFIBRATE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lipofen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRATE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 616852, 616853, 702055, 702169 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-306-90 | Lipofen | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-306 | LIPOFEN (FENOFIBRATE) CAPSULE [ANI PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20210927_78b789b9-854f-46b9-97f3-a48759a6ff89.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 |
|---|
| 62559-306-90 | 62559030690 | 90 CAPSULE in 1 BOTTLE (62559-306-90) | 90 capsule | 2021-09-24 | 0000-00-00 | No | No | Current |