FENOFIBRIC ACID 45 mg/1
FENOFIBRIC ACID · CAPSULE, DELAYED RELEASE · Aurobindo Pharma Limited
FENOFIBRIC ACID is a capsule, delayed release containing fenofibric acid at 45 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.
Key Facts
- Brand Name
- FENOFIBRIC ACID
- Generic Name
- FENOFIBRIC ACID
- NDC Code (Product)
59651-216- Manufacturer
- Aurobindo Pharma Limited
- Strength
- 45 mg/1
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA212598
- Drug Class
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
- Marketing Start
- 07/25/2019
Recall History
Mutual Pharmaceutical Company, Inc.
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Tribute Pharmaceuticals US Inc.
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Tribute Pharmaceuticals US Inc.
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Mutual Pharmaceutical Company, Inc.
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Mutual Pharmaceutical Company, Inc.
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Frequently Asked Questions
What is FENOFIBRIC ACID used for?
FENOFIBRIC ACID contains FENOFIBRIC ACID. It is a capsule, delayed release taken oral. Consult your doctor for specific uses.
Is FENOFIBRIC ACID a controlled substance?
FENOFIBRIC ACID is not classified as a controlled substance by the DEA.
What is the generic name for FENOFIBRIC ACID?
The generic name for FENOFIBRIC ACID is FENOFIBRIC ACID. There are 10 other brand versions of FENOFIBRIC ACID.
What is the NDC code for FENOFIBRIC ACID 45 mg/1?
The NDC (National Drug Code) for FENOFIBRIC ACID 45 mg/1 is 59651-216, listed by Aurobindo Pharma Limited.
Other FENOFIBRIC ACID Dosages
Other Fenofibric Brands
See all →- Fenofibric Acid135 mg/10115-1555
- FENOFIBRIC ACID DELAYED-RELEASE45 mg/142385-944
- FENOFIBRIC ACID DELAYED-RELEASE135 mg/142385-945
- Fenofibric Acid45 mg/162332-244
- Fenofibric acid45 mg/168180-128
- Fenofibric acid45 mg/133342-294
- Fenofibric Acid135 mg/146708-245
- Fenofibric acid135 mg/133342-295
- Fenofibric Acid45 mg/10115-1554
- Fenofibric acid45 mg/142571-347
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)