Fenofibric acid
- Product NDC
- 33342-294
- 11-digit product format
- 333420294
- Labeler code
- 33342
- Product ID
- 33342-294_94a44831-98b3-41d4-89da-89a43b25d15f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibric acid
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA207796
- Marketing category
- ANDA
- Marketing start
- 2024-02-26
- Substance
- CHOLINE FENOFIBRATE
- Active strength
- 45 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
- Fenofibric acid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHOLINE FENOFIBRATE | 45 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4BMH7IZT98 |
| Rxcui | 828373, 828379 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-294-10 | Fenofibric acid | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 2 |
| 33342-294-12 | Fenofibric acid | 10 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 10 | | 2 |
| 33342-294-12 | Fenofibric acid | 10 in 1 CARTON | CAPSULE, DELAYED RELEASE | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-294 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 3 package rows | 20240228_af225492-73b0-49bb-b32f-5399c3c3ec6d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-294-10 | 33342029410 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-294-10) | | 2024-02-26 | No | No | Current |
| 33342-294-12 | 33342029412 | 10 BLISTER PACK in 1 CARTON (33342-294-12) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 10 blister pack | 2024-02-26 | No | No | Current |