Fenofibrate
- Product NDC
- 62135-838
- 11-digit product format
- 621350838
- Labeler code
- 62135
- Product ID
- 62135-838_1cd4678b-5481-7a6e-e063-6394a90a56e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA209660
- Marketing category
- ANDA
- Marketing start
- 2019-02-11
- Substance
- FENOFIBRATE
- Active strength
- 160 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 | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 349287, 351133 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-838-90 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-838 | FENOFIBRATE TABLET, FILM COATED [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20240710_cc9d1672-5f82-45a1-b862-859703b3dc37.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-838-90 | 62135083890 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-838-90) | 2024-07-05 | No | No | Historical |