Fenofibrate
- Product NDC
- 0378-3065
- 11-digit product format
- 003783065
- Labeler code
- 0378
- Product ID
- 0378-3065_5683e52e-e8f1-47ab-a77b-ade2abe12c07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA202856
- Marketing category
- ANDA
- Marketing start
- 2013-05-14
- 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 |
|---|
| 0378-3065-05 | Fenofibrate | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 13 |
| 0378-3065-77 | Fenofibrate | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FENOFIBRATE | ACTIVE INGREDIENT | U202363UOS | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| FENOFIBRATE | ACTIVE MOIETY | U202363UOS | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| FENOFIBRATE | ACTIVE INGREDIENT | U202363UOS | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| FENOFIBRATE | ACTIVE MOIETY | U202363UOS | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-3065 | FENOFIBRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240216_0f958942-1504-40a1-8ad8-43df2c3f717e.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 |
|---|
| 0378-3065-05 | 00378306505 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3065-05) | 2013-05-14 | 2021-09-30 | No | No | Current |
| 0378-3065-77 | 00378306577 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3065-77) | 2013-05-14 | 0000-00-00 | No | No | Current |