NDC 13310-101

FIBRICOR

Fenofibric Acid

FIBRICOR is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ar Scientific, Inc.. The primary component is Fenofibric Acid.

• Product ID: 13310-101_26bcf80c-8314-4e10-b32c-452dbce94f7a
• NDC: 13310-101
• Product Type: Human Prescription Drug
• Proprietary Name: FIBRICOR
• Generic Name: Fenofibric Acid
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-08-14
• Marketing Category: NDA / NDA
• Application Number: NDA022418
• Labeler Name: AR Scientific, Inc.
• Substance Name: FENOFIBRIC ACID
• Active Ingredient Strength: 35 mg/1
• Pharm Classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 13310-101-07

30 TABLET in 1 BOTTLE, PLASTIC (13310-101-07)

• Marketing Start Date: 2009-08-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13310-101-06 [13310010106]

FIBRICOR TABLET

• Marketing Category: NDA
• Application Number: NDA022418
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-08-14
• Inactivation Date: 2019-11-27

NDC 13310-101-05 [13310010105]

FIBRICOR TABLET

• Marketing Category: NDA
• Application Number: NDA022418
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-08-14
• Inactivation Date: 2019-11-27

NDC 13310-101-07 [13310010107]

FIBRICOR TABLET

• Marketing Category: NDA
• Application Number: NDA022418
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-08-14
• Inactivation Date: 2019-11-27

NDC 13310-101-03 [13310010103]

FIBRICOR TABLET

• Marketing Category: NDA
• Application Number: NDA022418
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-08-14
• Inactivation Date: 2019-11-27

NDC 13310-101-90 [13310010190]

FIBRICOR TABLET

• Marketing Category: NDA
• Application Number: NDA022418
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-08-14
• Inactivation Date: 2019-11-27

NDC 13310-101-01 [13310010101]

FIBRICOR TABLET

• Marketing Category: NDA
• Application Number: NDA022418
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-08-14
• Inactivation Date: 2019-11-27

NDC 13310-101-10 [13310010110]

FIBRICOR TABLET

• Marketing Category: NDA
• Application Number: NDA022418
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-08-14
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
FENOFIBRIC ACID	35 mg/1

OpenFDA Data

• SPL SET ID: 86c49aff-0a4a-46b5-ac6e-26789bf17c9b
• Manufacturer:
  • AR Scientific, Inc.
• UNII:
  • BGF9MN2HU1
• RxNorm Concept Unique ID - RxCUI:
  • 860880
  • 860888
  • 860884
  • 860886
• UPC Code:
  • 0313310102013
  • 0313310101016

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