NDC 70347-105
FIBRICOR
Fenofibric Acid
FIBRICOR is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aralez Pharmaceuticals Us Inc.. The primary component is Fenofibric Acid.
| Product ID | 70347-105_3f1da578-fd1e-4f75-b179-98bd4aef4178 |
| NDC | 70347-105 |
| Product Type | Human Prescription Drug |
| Proprietary Name | FIBRICOR |
| Generic Name | Fenofibric Acid |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-08-05 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022418 |
| Labeler Name | Aralez Pharmaceuticals US Inc. |
| Substance Name | FENOFIBRIC ACID |
| Active Ingredient Strength | 105 mg/1 |
| Pharm Classes | Peroxisome Proliferator Receptor alpha Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 70347-105-07
7 TABLET in 1 BOTTLE, PLASTIC (70347-105-07)
| Marketing Start Date | 2017-08-05 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 70347-105-30 [70347010530]
FIBRICOR TABLET
| Marketing Category | NDA |
| Application Number | NDA022418 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-08-05 |
| Inactivation Date | 2020-01-31 |
NDC 70347-105-07 [70347010507]
FIBRICOR TABLET
| Marketing Category | NDA |
| Application Number | NDA022418 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-05 |
| Inactivation Date | 2020-01-31 |
NDC 70347-105-90 [70347010590]
FIBRICOR TABLET
| Marketing Category | NDA |
| Application Number | NDA022418 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-08-05 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| FENOFIBRIC ACID | 105 mg/1 |
OpenFDA Data
| SPL SET ID: | 31c80f84-0169-4659-b9cf-8f897ed319eb |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Crossover Matching brand name "FIBRICOR" or generic name "Fenofibric Acid"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 13310-101 | FIBRICOR | Fenofibric Acid |
| 13310-102 | FIBRICOR | Fenofibric Acid |
| 69916-035 | FIBRICOR | FIBRICOR |
| 69916-105 | FIBRICOR | FIBRICOR |
| 70347-105 | FIBRICOR | FIBRICOR |
| 70347-035 | FIBRICOR | FIBRICOR |
| 49708-102 | FIBRICOR | FIBRICOR |
| 49708-101 | FIBRICOR | FIBRICOR |
| 71511-501 | FIBRICOR | FIBRICOR |
| 71511-502 | FIBRICOR | FIBRICOR |
| 0115-1554 | Fenofibric Acid | Fenofibric Acid |
| 0115-1555 | Fenofibric Acid | Fenofibric Acid |
| 0228-2838 | fenofibric acid | fenofibric acid |
| 0228-2839 | fenofibric acid | fenofibric acid |
| 0378-2589 | Fenofibric Acid | fenofibric acid |
| 0378-2590 | Fenofibric Acid | fenofibric acid |
| 10370-209 | Fenofibric Acid | Fenofibric Acid |
| 10370-210 | Fenofibric Acid | Fenofibric Acid |
| 24979-109 | Fenofibric Acid | Fenofibric Acid |
| 24979-112 | Fenofibric Acid | Fenofibric Acid |
| 42385-944 | FENOFIBRIC ACID DELAYED-RELEASE | FENOFIBRIC ACID |
| 42385-945 | FENOFIBRIC ACID DELAYED-RELEASE | Fenofibric Acid |
| 0074-3161 | Trilipix | Fenofibric Acid |
| 0074-3162 | Trilipix | Fenofibric Acid |
| 0074-9189 | Trilipix | Fenofibric Acid |
| 0074-9642 | Trilipix | Fenofibric Acid |
Trademark Results [FIBRICOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIBRICOR 77574728 3729598 Live/Registered |
ATHENA BIOSCIENCE, LLC 2008-09-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.