fenofibrate
- Product NDC
- 0615-8270
- 11-digit product format
- 006158270
- Labeler code
- 0615
- Product ID
- 0615-8270_ba5a6f15-4de9-446b-9cb2-16b58a3d207d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA210138
- Marketing category
- ANDA
- Marketing start
- 2018-07-20
- Substance
- FENOFIBRATE
- Active strength
- 160 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
- fenofibrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRATE | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 349287 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8270-39 | fenofibrate | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8270 | FENOFIBRATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | Current NDC, Legacy NDC, 1 package rows | 20190309_fafbc0be-f0ba-4dcd-8aa5-89527bae5e84.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 |
|---|
| 0615-8270-39 | 00615827039 | 30 TABLET in 1 BLISTER PACK (0615-8270-39) | 30 tablet | 2019-02-04 | 0000-00-00 | No | No | Current |