Fenofibrate
- Product NDC
- 63304-448
- 11-digit product format
- 633040448
- Labeler code
- 63304
- Product ID
- 63304-448_5f5e6f81-fe5a-4ad6-be4e-0cf5f28a0f00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA200884
- Marketing category
- ANDA
- Marketing start
- 2018-06-01
- Marketing end
- 0000-00-00
- Substance
- FENOFIBRATE
- Active strength
- 48 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-448-05 | Fenofibrate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 12 |
| 63304-448-30 | Fenofibrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
| 63304-448-90 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-448 | FENOFIBRATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 12 | Legacy NDC, 3 package rows | 20250130_125bbd7e-86a2-4209-90a5-ad353e572d1b.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 |
|---|
| 63304-448-05 | 63304044805 | 500 TABLET, FILM COATED in 1 BOTTLE (63304-448-05) | 2018-06-01 | 0000-00-00 | No | No | Current |
| 63304-448-30 | 63304044830 | 30 TABLET, FILM COATED in 1 BOTTLE (63304-448-30) | 2018-06-01 | 0000-00-00 | No | No | Current |
| 63304-448-90 | 63304044890 | 90 TABLET, FILM COATED in 1 BOTTLE (63304-448-90) | 2018-06-01 | 0000-00-00 | No | No | Current |