Fenofibrate
- Product NDC
- 0115-0511
- 11-digit product format
- 001150511
- Labeler code
- 0115
- Product ID
- 0115-0511_4faa7be9-6cb4-4192-a287-555ad2ba3cbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA075868
- Marketing category
- ANDA
- Marketing start
- 2010-02-01
- Marketing end
- 2023-12-07
- Substance
- FENOFIBRATE
- Active strength
- 67 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 0115-0511-01 | Fenofibrate | 100 in 1 BOTTLE | CAPSULE | 100 | | 48 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FENOFIBRATE | ACTIVE INGREDIENT | U202363UOS | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| FENOFIBRATE | ACTIVE MOIETY | U202363UOS | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FENOFIBRATE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-0511 | FENOFIBRATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 48 | Legacy NDC, 1 package rows | 20221208_bfc6668c-3f69-4dd3-bc19-0d26c23dd04c.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 |
|---|
| 0115-0511-01 | 00115051101 | 100 CAPSULE in 1 BOTTLE (0115-0511-01) | 100 capsule | 2010-02-01 | 2023-12-07 | No | No | Current |