Fenofibrate
- Product NDC
- 68180-231
- 11-digit product format
- 681800231
- Labeler code
- 68180
- Product ID
- 68180-231_a70e38c8-07c1-4df6-8c2b-b5e0df3c304d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA204019
- Marketing category
- ANDA
- Marketing start
- 2020-07-01
- Substance
- FENOFIBRATE
- Active strength
- 54 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 68180-231_a70e38c8-07c1-4df6-8c2b-b5e0df3c304d
- SPL ID
- a70e38c8-07c1-4df6-8c2b-b5e0df3c304d
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Fenofibrate
- Generic name
- Fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2020-07-01
- Marketing category
- ANDA
- Application number
- ANDA204019
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| FENOFIBRATE | 54 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 349287, 351133 |
| Spl Set Id | 4cb6617c-f787-470f-81d8-0aba46df937f |
| Manufacturer Name | Lupin Pharmaceuticals, Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 68180-231-09 | 90 TABLET in 1 BOTTLE (68180-231-09) | 2020-07-01 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| U202363UOS | FENOFIBRATE | 49562-28-9 | FENOFIBRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68180-231-09 | 68180023109 | 90 TABLET in 1 BOTTLE (68180-231-09) | 90 tablet | 2020-07-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fenofibrate | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2025-11-19 | HUMAN PRESCRIPTION DRUG LABEL | 19 |
| Fenofibrate | A-S Medication Solutions | 2024-04-30 | HUMAN PRESCRIPTION DRUG LABEL | 6 |