Fenofibric Acid
- Product NDC
- 0115-1324
- 11-digit product format
- 001151324
- Labeler code
- 0115
- Product ID
- 0115-1324_a1c48695-091f-4924-acf4-a420be16939d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRIC ACID
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA200264
- Marketing category
- ANDA
- Marketing start
- 2024-06-01
- Substance
- FENOFIBRIC ACID
- Active strength
- 45 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
- Fenofibric Acid
- Listing expiration
- 2026-12-31
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 |
|---|
| 0115-1324-10 | Fenofibric Acid | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1324 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 7 | Current NDC, 1 package rows | 20240606_e73404c5-e0ee-48e9-8b09-7a00d7e18e6c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0115-1324-10 | 00115132410 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1324-10) | 2024-06-01 | No | No | Current |