NDC 0378-2589

Fenofibric Acid

Fenofibric Acid

Fenofibric Acid is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Fenofibric Acid.

• Product ID: 0378-2589_5c506b03-234c-420a-af44-3b08f4f80540
• NDC: 0378-2589
• Product Type: Human Prescription Drug
• Proprietary Name: Fenofibric Acid
• Generic Name: Fenofibric Acid
• Dosage Form: Capsule, Delayed Release Pellets
• Route of Administration: ORAL
• Marketing Start Date: 2013-07-15
• Marketing End Date: 2019-05-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200913
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: FENOFIBRIC ACID
• Active Ingredient Strength: 45 mg/1
• Pharm Classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0378-2589-77

90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2589-77)

• Marketing Start Date: 2013-07-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-2589-05 [00378258905]

Fenofibric Acid CAPSULE, DELAYED RELEASE PELLETS

• Marketing Category: ANDA
• Application Number: ANDA200913
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-07-15
• Marketing End Date: 2015-06-04

NDC 0378-2589-93 [00378258993]

Fenofibric Acid CAPSULE, DELAYED RELEASE PELLETS

• Marketing Category: ANDA
• Application Number: ANDA200913
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-07-15
• Marketing End Date: 2015-06-04

NDC 0378-2589-77 [00378258977]

Fenofibric Acid CAPSULE, DELAYED RELEASE PELLETS

• Marketing Category: ANDA
• Application Number: ANDA200913
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-07-15
• Marketing End Date: 2019-05-31

Drug Details

Active Ingredients

Ingredient	Strength
FENOFIBRIC ACID	45 mg/1

OpenFDA Data

• SPL SET ID: 05f08d62-9de9-4af9-931e-10b93c70e39e
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • BGF9MN2HU1
• RxNorm Concept Unique ID - RxCUI:
  • 828373
  • 828379
• UPC Code:
  • 0303782590777

Pharmacological Class

• Peroxisome Proliferator Receptor alpha Agonist [EPC]

NDC Crossover Matching brand name "Fenofibric Acid" or generic name "Fenofibric Acid"

NDC	Brand Name	Generic Name
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
68180-128	Fenofibric acid	Fenofibric acid
68180-129	Fenofibric acid	Fenofibric acid
68382-232	Fenofibric Acid	Fenofibric Acid
68382-233	Fenofibric Acid	Fenofibric Acid
69973-035	Fenofibric Acid	Fenofibric Acid
69973-105	Fenofibric Acid	Fenofibric Acid
46708-245	Fenofibric Acid	Fenofibric Acid
46708-244	Fenofibric Acid	Fenofibric Acid
53489-678	Fenofibric Acid	Fenofibric Acid
53489-677	Fenofibric Acid	Fenofibric Acid
62332-245	Fenofibric Acid	Fenofibric Acid
62332-244	Fenofibric Acid	Fenofibric Acid
50090-4373	Fenofibric acid	Fenofibric acid
59651-217	FENOFIBRIC ACID	FENOFIBRIC ACID
59651-216	FENOFIBRIC ACID	FENOFIBRIC ACID
50090-4561	Fenofibric Acid	Fenofibric Acid
72834-105	Fenofibric Acid	Fenofibric Acid
72834-035	Fenofibric Acid	Fenofibric Acid
68134-602	Fenofibric Acid	Fenofibric Acid
42571-348	Fenofibric acid	Fenofibric acid
68134-601	Fenofibric Acid	Fenofibric Acid
42571-347	Fenofibric acid	Fenofibric acid
42385-944	FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID
42385-945	FENOFIBRIC ACID DELAYED-RELEASE	Fenofibric Acid
13310-101	FIBRICOR	Fenofibric Acid
13310-102	FIBRICOR	Fenofibric Acid
0074-3161	Trilipix	Fenofibric Acid
0074-3162	Trilipix	Fenofibric Acid
0074-9189	Trilipix	Fenofibric Acid
0074-9642	Trilipix	Fenofibric Acid