NDC 70785-011

Zurampic

Lesinurad

Zurampic 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.

• Product ID: 70785-011_e0be03b1-e321-4297-b525-8151c03ab903
• NDC: 70785-011
• Product Type: Human Prescription Drug
• Proprietary Name: Zurampic
• Generic Name: Lesinurad
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-10-03
• Marketing End Date: 2020-07-31
• Marketing Category: NDA / NDA
• Application Number: NDA207988
• Labeler Name: Ironwood Pharmaceuticals, Inc.
• Substance Name: LESINURAD
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Urate Transporter 1 Inhibitor [EPC],Urate Transporter 1 Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA]
• NDC Exclude Flag: N

Packaging

NDC 70785-011-30

30 TABLET, FILM COATED in 1 BOTTLE (70785-011-30)

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

NDC SPL Data Element Entries

NDC 70785-011-05 [70785001105]

Zurampic TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207988
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-03
• Marketing End Date: 2020-07-31

NDC 70785-011-30 [70785001130]

Zurampic TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207988
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-03
• Marketing End Date: 2020-07-31

Drug Details

Active Ingredients

Ingredient	Strength
LESINURAD	200 mg/1

OpenFDA Data

• SPL SET ID: ef9e7711-f478-4e35-bf4e-6021c8457e3b
• Manufacturer:
  • Ironwood Pharmaceuticals, Inc.
• UNII:
  • 09ERP08I3W
• RxNorm Concept Unique ID - RxCUI:
  • 1731036
  • 1731042
• UPC Code:
  • 0370785011301

Pharmacological Class

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

NDC Crossover Matching brand name "Zurampic" or generic name "Lesinurad"

NDC	Brand Name	Generic Name
0310-1475	ZURAMPIC	lesinurad
70785-011	Zurampic	lesinurad