Fenofibrate
- Product NDC
- 51079-608
- 11-digit product format
- 510790608
- Labeler code
- 51079
- Product ID
- 51079-608_3ac22e61-98d2-068c-e063-6394a90ae338
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA202856
- Marketing category
- ANDA
- Marketing start
- 2013-06-10
- Substance
- FENOFIBRATE
- Active strength
- 145 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 | 145 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 |
|---|
| 51079-608-01 | Fenofibrate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 12 |
| 51079-608-20 | Fenofibrate | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| 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 |
|---|
| 51079-608 | FENOFIBRATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20220717_5a90e0a4-7892-462f-9776-037d23a93b10.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 |
|---|
| 51079-608-01 | 51079060801 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 51079-608-20 | 51079060820 | 100 BLISTER PACK in 1 CARTON (51079-608-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-608-01) | 100 blister pack | 2013-06-10 | 0000-00-00 | No | No | Current |