fenofibrate
- Product NDC
- 27241-117
- 11-digit product format
- 272410117
- Labeler code
- 27241
- Product ID
- 27241-117_698b59bf-d672-4ea4-8f3d-dcaee5329a39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenofibrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA210138
- Marketing category
- ANDA
- Marketing start
- 2018-07-20
- Substance
- FENOFIBRATE
- Active strength
- 160 mg/1
- Pharmacologic classes
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- fenofibrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FENOFIBRATE | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U202363UOS |
| Rxcui | 349287, 351133 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27241-117-03 | fenofibrate | 90 in 1 BOTTLE | TABLET | 90 | | 15 |
| 27241-117-05 | fenofibrate | 500 in 1 BOTTLE | TABLET | 500 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27241-117 | FENOFIBRATE TABLET [AJANTA PHARMA USA INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20241207_eb400ea7-bbd8-440b-b8be-082121621408.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 |
|---|
| 27241-117-03 | 27241011703 | 90 TABLET in 1 BOTTLE (27241-117-03) | 90 tablet | 2018-07-20 | 0000-00-00 | No | No | Current |
| 27241-117-05 | 27241011705 | 500 TABLET in 1 BOTTLE (27241-117-05) | 500 tablet | 2018-07-20 | 0000-00-00 | No | No | Current |