43353-880 : Ranexa 500 mg Oral Tablet, Film Coated, Extended Release


NDC: 43353-880
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product Type: Human Prescription Drug
Drug Name:  Ranexa
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA021526
Rev. Date: 


Appearance:


Markings: GSI500
Shapes:  Oval
Colors:  Orange
Size (mm): 17
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.

GSI500: (61958-1001) Ranexa 500 mg Oral Tablet, Film Coated, Extended Release by Aphena Pharma Solutions - Tennessee, LLC
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:

  • 43353-880-83: 3600 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (43353‑880‑83)

Active Ingredients:

  • Ranolazine

Dosage Strength:

  • 500 mg

Inactive Ingredients:

  • Carnauba Wax
  • Hypromelloses
  • Magnesium Stearate
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Cellulose, Microcrystalline
  • Sodium Hydroxide
  • Polyvinyl Alcohol
  • Titanium Dioxide
  • Polyethylene Glycol 3350
  • Talc
  • Ferric Oxide Yellow
  • Ferric Oxide Red
  • Water

Pharmaceutical Classes:

  • Anti-anginal [EPC]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • Cytochrome P450 3A Inhibitors [MoA]
  • Organic Cation Transporter 2 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 55154-4427 Ranexa 500 mg 12 Hr Extended Release Tablet by Cardinal Health
  • 55154-4428 Ranexa 500 mg 12 Hr Extended Release Tablet by Cardinal Health
  • 61958-1001 Ranexa 500 mg 12 Hr Extended Release Tablet by Gilead Sciences, Inc.
  • 61958-1002 Ranexa 1000 mg 12 Hr Extended Release Tablet by Gilead Sciences, Inc.
  • 61958-1003 Ranexa 500 mg 12 Hr Extended Release Tablet by Gilead Sciences, Inc.
  • 61958-1004 Ranexa 1000 mg 12 Hr Extended Release Tablet by Gilead Sciences, Inc.
  • 68151-5004 Ranexa 500 mg Oral Tablet, Film Coated, Extended Release by Carilion Materials Management

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.