61958-1004 : Ranexa 1000 mg 12 Hr Extended Release Tablet


NDC: 61958-1004
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: GSI1000
Shapes:  Oval
Colors:  Yellow
Size (mm): 21
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.

GSI1000: (61958-1004) Ranexa 1000 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:

  • 61958-1004-1: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (61958‑1004‑1)
  • 61958-1004-2: 14 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (61958‑1004‑2)
  • 61958-1004-3: 14 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BLISTER PACK (61958‑1004‑3)

Active Ingredients:

  • Ranolazine

Dosage Strength:

  • 1000 mg

Inactive Ingredients:

  • Carnauba Wax
  • Hypromelloses
  • Magnesium Stearate
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Cellulose, Microcrystalline
  • Sodium Hydroxide
  • Polyethylene Glycol 3350
  • Titanium Dioxide
  • Lactose Monohydrate
  • Triacetin
  • Ferric Oxide Yellow
  • Hypromellose 2910 (6 Mpa.s)
  • Water

Pharmaceutical Classes:

  • Anti-anginal [EPC]

Related Products:

Based on records with the same trade name.
  • 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.
  • 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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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.