NDC 70347-035

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: 70347-035_3f1da578-fd1e-4f75-b179-98bd4aef4178
• NDC: 70347-035
• 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: 35 mg/1
• Pharm Classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70347-035-30

30 TABLET in 1 BOTTLE, PLASTIC (70347-035-30)

• Marketing Start Date: 2017-08-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70347-035-30 [70347003530]

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	35 mg/1

OpenFDA Data

• SPL SET ID: 31c80f84-0169-4659-b9cf-8f897ed319eb
• Manufacturer:
  • Aralez Pharmaceuticals US Inc.
• UNII:
  • BGF9MN2HU1
• RxNorm Concept Unique ID - RxCUI:
  • 860880
  • 860888
  • 860884
  • 860886
• UPC Code:
  • 0370347035301
  • 0370347105301

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