NDC 69844-022

FENOFIBRIC ACID DELAYED-RELEASE

Fenofibric Acid

FENOFIBRIC ACID DELAYED-RELEASE is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Graviti Pharmaceuticals Private Limited. The primary component is Fenofibric Acid.

• Product ID: 69844-022_3413a8cc-557c-4a07-8789-577b77967040
• NDC: 69844-022
• Product Type: Human Prescription Drug
• Proprietary Name: FENOFIBRIC ACID DELAYED-RELEASE
• Generic Name: Fenofibric Acid
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA211626
• Labeler Name: Graviti Pharmaceuticals Private Limited
• Substance Name: FENOFIBRIC ACID
• Active Ingredient Strength: 45 mg/1
• Pharm Classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 69844-022-01

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69844-022-01)

• Marketing Start Date: 2019-07-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69844-022-03 [69844002203]

FENOFIBRIC ACID DELAYED-RELEASE CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA211626
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-18

NDC 69844-022-02 [69844002202]

FENOFIBRIC ACID DELAYED-RELEASE CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA211626
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-18

NDC 69844-022-01 [69844002201]

FENOFIBRIC ACID DELAYED-RELEASE CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA211626
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-18

Drug Details

Active Ingredients

Ingredient	Strength
FENOFIBRIC ACID	45 mg/1

OpenFDA Data

• SPL SET ID: 865b1149-4b66-4150-a023-8448b2c05cd7
• Manufacturer:
  • Graviti Pharmaceuticals Private Limited
• UNII:
  • BGF9MN2HU1
• RxNorm Concept Unique ID - RxCUI:
  • 828373
  • 828379
• UPC Code:
  • 0369844022013

Pharmacological Class

• Peroxisome Proliferator Receptor alpha Agonist [EPC]
• Peroxisome Proliferator Receptor alpha Agonist [EPC]

NDC Crossover Matching brand name "FENOFIBRIC ACID DELAYED-RELEASE" or generic name "Fenofibric Acid"

NDC	Brand Name	Generic Name
42385-944	FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID
42385-945	FENOFIBRIC ACID DELAYED-RELEASE	Fenofibric Acid
60429-432	Fenofibric Acid Delayed-Release	Fenofibric Acid Delayed-Release
69844-023	FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID DELAYED-RELEASE
69844-022	FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID DELAYED-RELEASE
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
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