0078-0607 : Gilenya 0.5 mg Oral Capsule

Labeler: Novartis Pharmaceuticals Corporation
Product Type: Human Prescription Drug
Drug Name:  Gilenya
Dosage Form: Oral Capsule
Application #: NDA022527
Rev. Date: 


Markings: FTY;0;5;mg
Shapes:  Capsule
Colors:  White / Yellow
Size (mm): 16
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.

FTY 0 5 mg: (0078-0607) Gilenya 0.5 mg Oral Capsule by Novartis Pharmaceuticals Corporation
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:

  • 0078-0607-15: 30 CAPSULE IN 1 BOTTLE (0078‑0607‑15)
  • 0078-0607-51: 28 CAPSULE IN 1 CARTON (0078‑0607‑51)
  • 0078-0607-89: 7 CAPSULE IN 1 CARTON (0078‑0607‑89)

Active Ingredients:

  • Fingolimod Hydrochloride

Dosage Strength:

  • .5 mg

Inactive Ingredients:

  • Gelatin
  • Magnesium Stearate
  • Mannitol
  • Titanium Dioxide
  • Ferric Oxide Yellow

Pharmaceutical Classes:

  • Sphingosine 1-Phosphate Receptor Modulators [MoA]
  • Sphingosine 1-phosphate Receptor Modulator [EPC]

Related Products:

Based on records with the same trade name.
  • 0078-0965 Gilenya .25 mg Oral Capsule by Novartis Pharmaceuticals Corporation


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NDC 0078-0607 QR Code

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