Fenofibrate
- Product NDC
- 68180-130
- 11-digit product format
- 681800130
- Labeler code
- 68180
- Product ID
- 68180-130_00a3d4e3-2364-47fd-919a-f336c12ece0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- NDA021695
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2013-02-22
- Substance
- FENOFIBRATE
- Active strength
- 43 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 | 43 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 483425, 483427 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-130-06 | Fenofibrate | 30 in 1 BOTTLE | CAPSULE | 30 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FENOFIBRATE | ACTIVE INGREDIENT | U202363UOS | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| FENOFIBRATE | ACTIVE MOIETY | U202363UOS | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| D&C BLACK NO. 2 | INACTIVE INGREDIENT | 4XYU5U00C4 | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| SULFUR DIOXIDE | INACTIVE INGREDIENT | 0UZA3422Q4 | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-130 | FENOFIBRATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20231103_37b25526-0bd0-4459-a4be-f3a6893506f9.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 |
|---|
| 68180-130-06 | 68180013006 | 30 CAPSULE in 1 BOTTLE (68180-130-06) | 30 capsule | 2013-02-22 | 0000-00-00 | No | No | Current |