FENOFIBRIC ACID
- Product NDC
- 59651-216
- 11-digit product format
- 596510216
- Labeler code
- 59651
- Product ID
- 59651-216_21dc5a32-9e47-415c-8b55-f97c5e7b15e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENOFIBRIC ACID
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA212598
- Marketing category
- ANDA
- Marketing start
- 2019-07-25
- Substance
- FENOFIBRIC ACID
- 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 |
|---|
| FENOFIBRIC ACID | 45 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BGF9MN2HU1 |
| Rxcui | 828373, 828379 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-216-90 | FENOFIBRIC ACID | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-216 | FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 1 package rows | 20210626_9ad201de-fa62-4c49-bc61-ee09b9ba434c.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 |
|---|
| 59651-216-90 | 59651021690 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-216-90) | 2019-07-25 | 0000-00-00 | No | No | Current |