Fenofibric Acid
- Product NDC
- 0115-1554
- 11-digit product format
- 001151554
- Labeler code
- 0115
- Product ID
- 0115-1554_72e2c9bb-63d6-4a3b-bee1-52a18e95bf0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibric Acid
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- NDA022224
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-09-12
- Marketing end
- 2026-07-31
- Substance
- FENOFIBRIC ACID
- Active strength
- 45 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fenofibric Acid
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRIC ACID | 45 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BGF9MN2HU1 |
| Rxcui | 828373, 828379 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-1554-10 | Fenofibric Acid | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 89 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1554 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 88 | Current NDC, Legacy NDC, 1 package rows | 20241206_369b3e55-2c05-d879-fe7e-91296c529ae9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0115-1554-10 | 00115155410 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1554-10) | 2016-09-12 | 2026-07-31 | No | No | Current |