NDC 70785-022

Duzallo

Lesinurad And Allopurinol

Duzallo is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ironwood Pharmaceuticals, Inc.. The primary component is Lesinurad; Allopurinol.

• Product ID: 70785-022_cb69308c-9652-4f7d-ad7a-6e84f48b5809
• NDC: 70785-022
• Product Type: Human Prescription Drug
• Proprietary Name: Duzallo
• Generic Name: Lesinurad And Allopurinol
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-10-03
• Marketing End Date: 2019-11-30
• Marketing Category: NDA / NDA
• Application Number: NDA209203
• Labeler Name: Ironwood Pharmaceuticals, Inc.
• Substance Name: LESINURAD; ALLOPURINOL
• Active Ingredient Strength: 200 mg/1; mg/1
• Pharm Classes: Urate Transporter 1 Inhibitor [EPC],Urate Transporter 1 Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 70785-022-05

5 TABLET, FILM COATED in 1 BOTTLE (70785-022-05)

• Marketing Start Date: 2017-10-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70785-022-30 [70785002230]

Duzallo TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209203
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-03
• Marketing End Date: 2019-11-30

NDC 70785-022-05 [70785002205]

Duzallo TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209203
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-03
• Marketing End Date: 2019-11-30

NDC 70785-022-90 [70785002290]

Duzallo TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209203
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-15
• Marketing End Date: 2017-11-08

Drug Details

Active Ingredients

Ingredient	Strength
LESINURAD	200 mg/1

OpenFDA Data

• SPL SET ID: d4bd0c41-90ce-4255-8ff3-a4d47a5b25f8
• Manufacturer:
  • Ironwood Pharmaceuticals, Inc.
• UNII:
  • 63CZ7GJN5I
  • 09ERP08I3W
• RxNorm Concept Unique ID - RxCUI:
  • 1944786
  • 1944779
  • 1944785
  • 1944788
• UPC Code:
  • 0370785021904
  • 0370785022901

Pharmacological Class

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

Medicade Reported Pricing

70785002230 DUZALLO 200-300 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Duzallo" or generic name "Lesinurad And Allopurinol"

NDC	Brand Name	Generic Name
70785-021	Duzallo	lesinurad and allopurinol
70785-022	Duzallo	lesinurad and allopurinol