53489-678 : Fenofibric Acid 105 mg Oral Tablet


NDC53489-678
Labeler: Mutual Pharmaceutical Company, Inc.
Product Type: Human Prescription Drug
Drug Name:  Fenofibric Acid
Dosage Form: Oral Tablet
Application #: NDA022418
Rev. Date: 


Appearance:


Markings: AR;788
Shapes:  Oval
Colors:  White
Size (mm): 19
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

AR 788: (53489-678) Fenofibric Acid 105 mg Oral Tablet by Mutual Pharmaceutical Company, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 53489-678-07: 30 TABLET IN 1 BOTTLE, PLASTIC (53489‑678‑07)
  • 53489-678-90: 90 TABLET IN 1 BOTTLE, PLASTIC (53489‑678‑90)

Active Ingredients:

  • Fenofibric Acid

Dosage Strength:

  • 105 mg

Inactive Ingredients:

  • Copovidone K25-31
  • Crospovidone
  • Magnesium Stearate
  • Cellulose, Microcrystalline

Pharmaceutical Classes:

  • Peroxisome Proliferator Receptor alpha Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 53489-677 Fenofibric Acid 35 mg Oral Tablet by Mutual Pharmaceutical Company, Inc.
  • 0115-1459 Fenofibric Acid 45 mg Delayed Release Capsule by Global Pharmaceuticals, Division of Impax Laboratories Inc.
  • 0115-1460 Fenofibric Acid 135 mg Delayed Release Capsule by Global Pharmaceuticals, Division of Impax Laboratories Inc.
  • 0115-1554 Fenofibric Acid 45 mg Oral Capsule, Delayed Release by Impax Generics
  • 0115-1555 Fenofibric Acid 135 mg Oral Capsule, Delayed Release by Impax Generics
  • 0228-2838 Fenofibric Acid 45 mg Oral Capsule, Delayed Release by Actavis Pharma, Inc.
  • 0228-2839 Fenofibric Acid 135 mg Oral Capsule, Delayed Release by Actavis Pharma, Inc.
  • 0378-2589 Fenofibric Acid 45 mg Delayed Release Capsule by Mylan Pharmaceuticals Inc.
  • 0378-2590 Fenofibric Acid 135 mg Delayed Release Capsule by Mylan Pharmaceuticals Inc.
  • 10370-209 Fenofibric Acid 45 mg Delayed Release Capsule by Par Pharmaceutical, Inc.
  • 10370-210 Fenofibric Acid 135 mg Delayed Release Capsule by Par Pharmaceutical, Inc.
  • 46708-244 Fenofibric Acid 45 mg Oral Capsule, Delayed Release by Alembic Pharmaceuticals Limited
  • 46708-245 Fenofibric Acid 135 mg Oral Capsule, Delayed Release by Alembic Pharmaceuticals Limited
  • 51079-195 Fenofibric Acid 45 mg/1 Oral Capsule, Delayed Release Pellets by Mylan Institutional Inc.
  • 51079-196 Fenofibric Acid 135 mg/1 Oral Capsule, Delayed Release Pellets by Mylan Institutional Inc.
  • 62332-244 Fenofibric Acid 45 mg Oral Capsule, Delayed Release by Alembic Pharmaceuticals Inc.
  • 62332-245 Fenofibric Acid 135 mg Oral Capsule, Delayed Release by Alembic Pharmaceuticals Inc.
  • 68180-128 Fenofibric Acid 45 mg/1 Oral Capsule, Delayed Release by Lupin Pharmaceuticals, Inc.
  • 68180-129 Fenofibric Acid 135 mg/1 Oral Capsule, Delayed Release by Lupin Pharmaceuticals, Inc.
  • 68382-077 Fenofibric Acid 45 mg/1 Oral Capsule, Delayed Release by Zydus Pharmaceuticals USA Inc
  • More related products ...

NDC QR Code

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