0378-5121 : Fluvastatin Sodium 80 mg Oral Tablet, Film Coated, Extended Release

Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Fluvastatin Sodium
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA202458
Rev. Date: 


Markings: M;F21
Shapes:  Round
Colors:  Red
Size (mm): 10
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:

  • 0378-5121-01: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑5121‑01)
  • 0378-5121-05: 500 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑5121‑05)
  • 0378-5121-93: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑5121‑93)

Active Ingredients:

  • Fluvastatin Sodium

Dosage Strength:

  • 80 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Starch, Corn
  • Hydroxypropyl Cellulose (Type H)
  • Hypromelloses
  • Lecithin, Soybean
  • Magnesium Stearate
  • Polyethylene Glycols
  • Polyvinyl Alcohol
  • Ferric Oxide Red
  • Sodium Lauryl Sulfate
  • Talc
  • Titanium Dioxide

Pharmaceutical Classes:

  • HMG-CoA Reductase Inhibitor [EPC]
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0378-8020 Fluvastatin (As Fluvastatin Sodium) 20 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-8021 Fluvastatin (As Fluvastatin Sodium) 40 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0093-7446 Fluvastatin Sodium 80 mg Oral Tablet, Film Coated, Extended Release by Teva Pharmaceuticals USA, Inc.
  • 0781-5370 Fluvastatin 80 mg 24 Hr Extended Release Tablet by Sandoz Inc
  • 68151-1326 Fluvastatin Sodium 20 mg Oral Capsule by Carilion Materials Management
  • 68151-1334 Fluvastatin Sodium 40 mg Oral Capsule by Carilion Materials Management


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