Fenofibrate
- Product NDC
- 63304-444
- 11-digit product format
- 633040444
- Labeler code
- 63304
- Product ID
- 63304-444_f26726b3-a91e-45bc-a02e-a560d898362a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA201748
- Marketing category
- ANDA
- Marketing start
- 2015-03-02
- Substance
- FENOFIBRATE
- Active strength
- 130 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 | 130 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 483425, 483427 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-444-05 | Fenofibrate | 500 in 1 BOTTLE | CAPSULE | 500 | | 11 |
| 63304-444-30 | Fenofibrate | 30 in 1 BOTTLE | CAPSULE | 30 | | 11 |
| 63304-444-90 | Fenofibrate | 90 in 1 BOTTLE | CAPSULE | 90 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-444 | FENOFIBRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20240830_2083f5d9-92f2-4c64-b996-fabbd6946ea0.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 |
|---|
| 63304-444-05 | 63304044405 | 500 CAPSULE in 1 BOTTLE (63304-444-05) | 500 capsule | 2015-03-02 | 0000-00-00 | No | No | Current |
| 63304-444-30 | 63304044430 | 30 CAPSULE in 1 BOTTLE (63304-444-30) | 30 capsule | 2015-03-02 | 0000-00-00 | No | No | Current |
| 63304-444-90 | 63304044490 | 90 CAPSULE in 1 BOTTLE (63304-444-90) | 90 capsule | 2015-03-02 | 0000-00-00 | No | No | Current |