Fenofibrate
- Product NDC
- 27241-120
- 11-digit product format
- 272410120
- Labeler code
- 27241
- Product ID
- 27241-120_2dffe879-0f18-4961-b1a9-0d69565a04a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA210705
- Marketing category
- ANDA
- Marketing start
- 2018-09-10
- Substance
- FENOFIBRATE
- Active strength
- 200 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 | 200 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 |
|---|
| 27241-120-04 | Fenofibrate | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 27241-120-05 | 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 |
|---|
| 27241-120 | FENOFIBRATE CAPSULE [AJANTA PHARMA USA INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241020_da2f0ba4-7c16-4fb0-bc1c-45540e8fefbf.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 |
|---|
| 27241-120-04 | 27241012004 | 100 CAPSULE in 1 BOTTLE (27241-120-04) | 100 capsule | 2018-09-10 | 0000-00-00 | No | No | Current |
| 27241-120-05 | 27241012005 | 500 CAPSULE in 1 BOTTLE (27241-120-05) | 500 capsule | 2019-08-01 | 0000-00-00 | No | No | Current |