Fenofibric Acid
- Product NDC
- 46708-245
- 11-digit product format
- 467080245
- Labeler code
- 46708
- Product ID
- 46708-245_4f5277a1-2983-4cf9-b589-714d5fc586c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fenofibric Acid
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA208705
- Marketing category
- ANDA
- Marketing start
- 2017-05-18
- Substance
- FENOFIBRIC ACID
- Active strength
- 135 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 |
|---|
| FENOFIBRIC ACID | 135 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BGF9MN2HU1 |
| Rxcui | 828373, 828379 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-245-30 | Fenofibric Acid | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 3 |
| 46708-245-90 | Fenofibric Acid | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 3 |
| 46708-245-91 | Fenofibric Acid | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-245 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20230202_c880d43a-fa8c-4f7a-a488-419bae7cc311.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-245-30 | 46708024530 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-30) | 2017-05-18 | 0000-00-00 | No | No | Current |
| 46708-245-90 | 46708024590 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-90) | 2017-05-18 | 0000-00-00 | No | No | Current |
| 46708-245-91 | 46708024591 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-91) | 2017-05-18 | 0000-00-00 | No | No | Current |