0006-0533 : Juvisync 50/10 (Sitagliptin 50 mg (Sitagliptin Phosphate Monohydrate 64.25 mg) / Simvastatin 10 mg) Oral Tablet

Labeler: Merck Sharp & Dohme Corp.
Product Type: Human Prescription Drug
Drug Name:  Juvisync
Dosage Form: Oral Tablet, Film Coated
Application #: NDA202343
Rev. Date: 


Markings: 533
Shapes:  Oval
Colors:  Red
Size (mm): 13
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:

  • 0006-0533-31: 30 TABLET, FILM COATED IN 1 BOTTLE (0006‑0533‑31)
  • 0006-0533-54: 90 TABLET, FILM COATED IN 1 BOTTLE (0006‑0533‑54)

Active Ingredients:

  • Simvastatin
  • Sitagliptin Phosphate

Dosage Strength:

  • 10 mg
  • 50 mg

Inactive Ingredients:

  • Calcium Phosphate, Dibasic, Anhydrous
  • Cellulose, Microcrystalline
  • Croscarmellose Sodium
  • Sodium Stearyl Fumarate
  • Magnesium Stearate
  • Ascorbic Acid
  • Citric Acid Monohydrate
  • Lactose Monohydrate
  • Starch, Corn
  • Polyvinyl Alcohol
  • Polyethylene Glycol 3350
  • Talc
  • Titanium Dioxide
  • Ferric Oxide Red
  • Butylated Hydroxyanisole

Pharmaceutical Classes:

  • Dipeptidyl Peptidase 4 Inhibitor [EPC]
  • Dipeptidyl Peptidase 4 Inhibitors [MoA]
  • HMG-CoA Reductase Inhibitor [EPC]
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0006-0535 Juvisync 50/20 Oral Tablet by Merck Sharp & Dohme Corp.
  • 0006-0537 Juvisync 50/40 Oral Tablet by Merck Sharp & Dohme Corp.
  • 0006-0753 Juvisync 100/10 (Sitagliptin / Simvastatin) Oral Tablet by Merck Sharp & Dohme Corp.
  • 0006-0757 Juvisync 100/20 (Sitagliptin / Simvastatin) Oral Tablet by Merck Sharp & Dohme Corp.
  • 0006-0773 Juvisync 100/40 (Sitagliptin / Simvastatin) Oral Tablet by Merck Sharp & Dohme Corp.


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