Fenofibrate
- Product NDC
- 31722-595
- 11-digit product format
- 317220595
- Labeler code
- 31722
- Product ID
- 31722-595_3a0bacd4-7a48-214e-e063-6394a90ac69f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA204598
- Marketing category
- ANDA
- Marketing start
- 2016-07-14
- Substance
- FENOFIBRATE
- Active strength
- 48 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 | 48 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 477560, 477562 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-595-30 | Fenofibrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 31722-595-31 | Fenofibrate | 100 in 1 BLISTER PACK | TABLET, FILM COATED | 100 | | 4 |
| 31722-595-32 | Fenofibrate | 100 in 1 BLISTER PACK | TABLET, FILM COATED | 100 | | 4 |
| 31722-595-90 | Fenofibrate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-595 | FENOFIBRATE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20160816_38f43148-4ca0-402a-ba39-8ee5011a7907.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 |
|---|
| 31722-595-30 | 31722059530 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-595-30) | 2016-07-14 | 0000-00-00 | No | No | Current |
| 31722-595-31 | 31722059531 | 100 TABLET, FILM COATED in 1 BLISTER PACK (31722-595-31) | 2016-07-14 | 0000-00-00 | No | No | Current |
| 31722-595-32 | 31722059532 | 100 TABLET, FILM COATED in 1 BLISTER PACK (31722-595-32) | 2016-07-14 | 0000-00-00 | No | No | Current |
| 31722-595-90 | 31722059590 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-595-90) | 2016-07-14 | 0000-00-00 | No | No | Current |