Fenofibrate
- Product NDC
- 68180-363
- 11-digit product format
- 681800363
- Labeler code
- 68180
- Product ID
- 68180-363_460a572c-5bf6-4767-a7f4-6b0156e59a6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA204019
- Marketing category
- ANDA
- Marketing start
- 2015-11-23
- Marketing end
- 2022-05-31
- Substance
- FENOFIBRATE
- Active strength
- 160 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FENOFIBRATE | ACTIVE INGREDIENT | U202363UOS | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| FENOFIBRIC ACID | ACTIVE MOIETY | BGF9MN2HU1 | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-363 | FENOFIBRATE TABLET [LUPIN PHARMACEUTICALS, INC.] | 18 | Legacy NDC | 20250316_4cb6617c-f787-470f-81d8-0aba46df937f.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 |
|---|
| 68180-363-02 | 68180036302 | 500 TABLET in 1 BOTTLE (68180-363-02) | 500 tablet | 2015-11-23 | 2022-05-31 | No | No | Current |
| 68180-363-03 | 68180036303 | 1000 TABLET in 1 BOTTLE (68180-363-03) | 1000 tablet | 2015-11-23 | 2022-05-31 | No | No | Current |
| 68180-363-09 | 68180036309 | 90 TABLET in 1 BOTTLE (68180-363-09) | 90 tablet | 2015-11-23 | 2022-05-31 | No | No | Current |
| 68180-363-13 | 68180036313 | 10 BLISTER PACK in 1 CARTON (68180-363-13) > 10 TABLET in 1 BLISTER PACK (68180-363-11) | 10 blister pack | 2015-11-23 | 2022-05-31 | No | No | Current |