70785-022 : Duzallo Oral Tablet, Film Coated

Labeler: Ironwood Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Duzallo
Dosage Form: Oral Tablet, Film Coated
Application #: NDA209203
Rev. Date: 


Markings: LES200;ALO300
Shapes:  Oval
Colors:  Brown
Size (mm): 19
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:

  • 70785-022-05: 5 TABLET, FILM COATED IN 1 BOTTLE (70785‑022‑05)
  • 70785-022-30: 30 TABLET, FILM COATED IN 1 BOTTLE (70785‑022‑30)
  • 70785-022-90: 90 TABLET, FILM COATED IN 1 BOTTLE (70785‑022‑90)

Active Ingredients:

  • Lesinurad
  • Allopurinol

Dosage Strength:

  • 200 mg
  • 300 mg

Inactive Ingredients:

  • Microcrystalline Cellulose
  • Lactose Monohydrate
  • Hydroxypropyl Cellulose, Unspecified
  • Crospovidone, Unspecified
  • Magnesium Stearate
  • Hypromellose, Unspecified
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Titanium Dioxide
  • Triacetin

Pharmaceutical Classes:

  • Urate Transporter 1 Inhibitor [EPC]
  • Urate Transporter 1 Inhibitors [MoA]
  • Cytochrome P450 3A Inducers [MoA]
  • Xanthine Oxidase Inhibitor [EPC]
  • Xanthine Oxidase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 70785-021 Duzallo Oral Tablet, Film Coated by Ironwood Pharmaceuticals, Inc.


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