61958-1001 : Ranexa 500 mg 12 Hr Extended Release Tablet


NDC61958-1001
Labeler: Gilead Sciences, Inc.
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 12 Hr Extended Release Tablet by Gilead Sciences, 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:

  • 61958-1001-1: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (61958‑1001‑1)

Active Ingredients:

  • Ranolazine

Dosage Strength:

  • 500 mg

Inactive Ingredients:

  • Carnauba Wax
  • Hypromellose 2910 (5 Cps)
  • Magnesium Stearate
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Cellulose, Microcrystalline
  • Sodium Hydroxide
  • Polyethylene Glycol 400
  • Titanium Dioxide
  • Polysorbate 80
  • Fd&c Yellow No. 6
  • Aluminum Oxide
  • Hypromellose 2910 (3 Cps)
  • Hypromellose 2910 (6 Cps)

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 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.
  • 43353-880 Ranexa 500 mg Oral Tablet, Film Coated, Extended Release by Aphena Pharma Solutions - Tennessee, LLC
  • 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
  • 68151-5004 Ranexa 500 mg Oral Tablet, Film Coated, Extended Release by Carilion Materials Management

NDC QR Code

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