68084-715 : Fenofibric Acid 135 mg Oral Capsule, Delayed Release


NDC68084-715
Labeler: American Health Packaging
Product Type: Human Prescription Drug
Drug Name:  Fenofibric Acid Delayed-release
Dosage Form: Oral Capsule, Delayed Release
Application #: ANDA201573
Rev. Date: 


Appearance:


Markings: C210;Par
Shapes:  Capsule
Colors:  Yellow / Blue
Size (mm): 22
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.

NDC Package Codes:

  • 68084-715-32: 20 BLISTER PACK IN 1 BOX, UNIT‑DOSE (68084‑715‑32) > 1 CAPSULE, DELAYED RELEASE IN 1 BLISTER PACK (68084‑715‑33)

Active Ingredients:

  • Choline Fenofibrate

Dosage Strength:

  • 135 mg

Inactive Ingredients:

  • Hydroxypropyl Cellulose (Type M)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Stearic Acid
  • Talc
  • Triethyl Citrate
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Fd&c Red No. 40
  • D&c Yellow No. 10
  • Ferrosoferric Oxide
  • Propylene Glycol
  • Shellac
  • Fd&c Yellow No. 6
  • Gelatin
  • Titanium Dioxide

Pharmaceutical Classes:

  • Peroxisome Proliferator Receptor alpha Agonist [EPC]
  • Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
  • PPAR alpha [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 24979-109 Fenofibric Acid 45 mg Oral Capsule, Delayed Release by Twi Pharmaceuticals, Inc.
  • 24979-112 Fenofibric Acid 135 mg Oral Capsule, Delayed Release by Twi Pharmaceuticals, Inc.
  • 42385-944 Fenofibric Acid Delayed-release Delayed-release 45 mg Oral Capsule, Delayed Release by Laurus Labs Limited
  • 42385-945 Fenofibric Acid Delayed-release Delayed-release 135 mg Oral Capsule, Delayed Release by Laurus Labs Limited
  • 60429-432 Fenofibric Acid 135 mg Oral Capsule, Delayed Release by Golden State Medical Supply, Inc.
  • 69844-022 Fenofibric Acid Delayed-release Delayed-release 45 mg Oral Capsule, Delayed Release by Graviti Pharmaceuticals Private Limited
  • 69844-023 Fenofibric Acid Delayed-release Delayed-release 135 mg Oral Capsule, Delayed Release by Graviti Pharmaceuticals Private Limited

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.